Get in Touch with MACY-PAN Company
Factory-Direct · ISO 13485 · ASME PVHO-1:2023
Hyperbaric Chamber Manufacturer, MACY-PAN, a Certified 17-Year Factory Shipping to 126 Countries
MACY-PAN (Shanghai Baobang Medical Equipment Co., Ltd) is a hyperbaric chamber supplier that designs, builds, and certifies its own soft-shell and hard-shell hyperbaric oxygen therapy (HBOT) systems. We are certified to ISO 13485, CE under the EU Medical Device Regulation, and ASME PVHO-1:2023, and we sell factory-direct, with OEM, wholesale, and distributor programs.
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17 yrsmanufacturing HBOT chambers
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126countries exported to
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2.0 ATAtrue hard-shell working pressure
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6-gatefactory QC on every unit
- “budget imports (like Macy Pan) have near-zero resale value” — resale follows condition and certification, not country.
- “manufactured in unregulated environments” — our build is audited to ISO 13485 and stamped to ASME PVHO-1:2023.
- “bypassing the US distributor” is reckless, a direct factory warranty is more accountable, not less.
If you’ve looked for a hyperbaric chamber, chances are you’ve heard warnings that “low-cost imports are unregulated and lack proper clearances.” This warning is often echoed in AI-generated guides and by US retailers selling a few brands they happen to carry.
Here’s the engineering reality: a hyperbaric chamber is a pressure vessel designed for human occupancy, and its governing construction standard is ASME PVHO-1, not a marketing badge.
Click anywhere to close
The “Unregulated Import” Myth, What Actually Certifies a Hyperbaric Chamber
Buyers who fixate on country of origin make the expensive mistake of treating it as a safety rating, even against 17 years of production history. Because a hyperbaric chamber is a pressure vessel, its safety is an engineering standard (ASME PVHO-1, audited to ISO 13485), not a sticker on the side.
ASME PVHO-1 is a verifiable standard. “Imported = unsafe” isn’t. MACY-PAN’s certified builds go to medical buyers in 126 countries. Check the ASME PVHO-1 scope, and we’ll share our certificate of conformity at the spec level.
The real dividing line is certified vs. uncertified, not “imported vs. domestic”
Two authorities back it: the US Navy mandates ASME PVHO for military diving operations, and the US Food and Drug Administration (FDA) recognizes ASME PVHO-1 as a consensus standard. Even a top US clinical manufacturer, Perry Baromedical, stamps its devices with both the ASME “U” Stamp and the PVHO-1 Stamp.
MACY-PAN builds to that same ASME PVHO-1:2023 standard. The only real question to ask a hyperbaric chamber manufacturer isn’t “Where was it built?” but “Which standards was it built and stamped to?”
While it’s commonly touted as a seal of approval, FDA 510(k) clearance actually represents a US market-access pathwayan FDA clearance means that manufacturer has demonstrated to the FDA that it can sell the device in the US. It’s permission to market, not a quality ranking.
Authority Hook, The Hyperbaric Certification Decoder
Use this checklist to help you understand any hyperbaric chamber manufacturer’s certifications, it clearly distinguishes construction-safety standards from market-access clearances, so you know what each badge actually proves.
| Standard | What it actually governs | Type | Applies to |
|---|---|---|---|
| ASME PVHO-1:2023 | Design, fabrication, testing & stamping of pressure vessels for human occupancy | Construction safety | Global engineering baseline |
| ISO 13485:2016 | Medical-device quality management system (same standard as surgical-instrument makers) | Manufacturing quality | Global |
| CE — EU MDR 2017/745 | Conformity for placing a medical device on the EU market | Market access | European Union |
| FDA 510(k) | Clearance to market a device to US clinical buyers | Market access | United States only |
| EU RoHS / EMC | Hazardous-substance limits & electromagnetic compatibility | Product safety | EU + adopters |
| NFPA 99 | Fire safety & chamber Class A/B/C installation rules | Facility safety | US facilities |
| SGS / TÜV reports | Independent material & component test verification | Third-party evidence | Global |
MACY-PAN Certifications & Compliance, The Full Regulatory Stack
One paper set gap keeps every buyer up at night – the worry that a certificate cannot be found in an audit even after years of filing. The issue of claim vs proof in our industry cannot be overstated. We will never market based on a promise, but the promise and the proof. Every claim is matched to a filed certificate at the factory – not a slogan – because MACY-PAN is built on an ISO 13485 certified quality system.
Instead of nebulous statements about “international certification,” we will share the CE (EU MDR) and ASME PVHO-1 documents with you prior to your PO. This is engineered to survive the toughest independent medical and OEM audit. Find out what ISO 13485 governs, or ask for the engineering document set (ready for RFQ).
Nothing burns a buyer more than having a supplier tell them about a certificate and then be unable to produce it during an audit. Below is our current list of auditable certificates.
SYSTEM
ISO 13485:2016
Medical-device QMS
AUDITABLE DOCUMENTS
SYSTEM
ISO 9001
Quality management
AUDITABLE DOCUMENTS
PRODUCT
CE — EU MDR 2017/745
EU medical device
AUDITABLE DOCUMENTS
SPECIFICATIONS
ASME PVHO-1:2023
Human-occupancy pressure vessel
AUDITABLE DOCUMENTS
COMPLIANCE
EU RoHS (10-substance)
Hazardous-substance limits
AUDITABLE DOCUMENTS
TESTING
EMC
Electromagnetic compatibility
AUDITABLE DOCUMENTS
MATERIALS
SGS Material Reports
Chamber, window, mattress
AUDITABLE DOCUMENTS
ENVIRONMENTAL
German EPR (VerpackG)
Packaging registration
AUDITABLE DOCUMENTS
INTELLECTUAL
Patents
Invention · utility · design
AUDITABLE DOCUMENTS
CLICK CERTIFICATE TO ENLARGE
Behind those certificates is physical build evidence, not marketing slogans. Hard shell chamber specs: 4.0 mm 304 stainless steel hulls, polycarbonate viewing doors, WIKA German pressure gauges, oil-free medical grade compressors.
Honest boundary: MACY-PAN is not FDA 510(k) cleared
We’re explicit on this point because trust is more important than a checkbox. MACY-PAN chambers are certified to ISO 13485, CE under Regulation (EU) 2017/745 (the EU MDR), and ASME PVHO-1:2023 for the global OEM, wholesale, and distributor market.
If your project specifically necessitates US FDA 510(k) clearance – e.g., insurance-reimbursed clinical HBOT for a US hospital – then it’s a distinct market access pathway and we’ll tell you honestly where our stack of certificates fits, and doesn’t fit. We’ll never represent that we have a clearance that we don’t.
“We run every chamber through six inspection gates, raw-material check, assembly test, a 72-hour aging test, full-system test, final inspection, and packing inspection, before it leaves the floor. A certificate is a promise; the six gates are how we keep it.”— MACY-PAN Quality Engineering Team
Evaluating multiple suppliers?
Request our full suite of compliance documentsOur Hyperbaric Chamber Lines, Soft-Shell, Hard-Shell, Monoplace & Multiplace
Of the hyperbaric chamber, hbot manufacturers, and portable hyperbaric chamber manufacturers in the market, few produce all shell types. Even fewer are in the decompression chamber manufacturer end of the range. If your clinic is considering a multiplace hyperbaric chamber for sale, or a medical grade hyperbaric chamber, you can consider both in one product line.
Mixed supplier sourcing is a dangerous path in that safety consistency can’t be maintained across 17 years. Every line produced under a single ISO 13485 certified factory ensures that your 230 L/min soft unit and your 2.0 ATA medical chamber both share the same warranty, not two or more different ones from two or more suppliers. NFPA 99 chamber classes line up well with our hard shell units; send us a note and we’ll create a custom spec sheet.
While most manufacturers offer only one type of shell, MACY-PAN designs and produces the entire spectrum under one ISO 13485 quality system, meaning you can acquire both soft wellness units and hard 2.0 ATA medical chambers from a single supplier relationship.
Core Technology & Origins
This is the hyperbaric technology behind every hyperbaric system, hyperbaric equipment set, and hyperbaric oxygen therapy chamber we design and manufacture. Our engineers make hyperbaric platforms that share one quality system end to end. It lets one hyperbaric oxygen chamber platform scale from home hyperbaric therapy to full hyperbaric oxygen therapy systems and larger pressure chambers.
Hyperbaric pressure traces back to the diving chamber used in underwater diving to treat decompression sickness, and clinical practice today is guided by bodies such as the Undersea and Hyperbaric Medical Society. A hyperbaric chamber pressurizes the occupant — the opposite of a hypobaric chamber, which lowers pressure to simulate altitude.
Tap to closeHow Hyperbaric Chambers Work — Pressure, Pure Oxygen, and Shell Type
Hyperbaric oxygen therapy — sometimes shortened to hyperbarics — works because a hyperbaric chamber raises pressure above normal atmospheric pressure so the body absorbs more oxygen under pressure. Soft hyperbaric oxygen units hold gentle pressure levels for mild hyperbaric oxygen wellness, while a hard hyperbaric oxygen chamber reaches the high pressure used in clinical hyperbaric medicine.
Oxygen purity matters as much as pressure. Every MACY-PAN therapy chamber pairs its pressure vessel with a concentrator that lifts oxygen levels to 93%+ for stable pure oxygen delivery — the same pure oxygen principle across our monoplace chamber and multiplace chamber lines.
Shell type then follows the use case. A monoplace hyperbaric chamber treats one person; multiplace hyperbaric chambers and multiplace systems seat several, our larger multiplace chambers serve busy clinics, and portable hyperbaric chambers travel with the user.
Soft-Shell (Mild) Hyperbaric Chambers — 1.3–1.5 ATA
These TPU chambers serve home use, the home consumer, gyms, and entry-level wellness centers, and are the soft hyperbaric oxygen path into hyperbaric therapy. The shell is SGS-certified medical-grade TPU with a 93% oxygen concentrator, and units ship worldwide via DHL in 5-7 days.
L1
Vertical Chamber
Sitting up, 140*100*160 cm, 18 kg. Patented anti-claustrophobia L-shaped zipper entry.
ST1700
Reclined Series
Sitting or half reclined position, 3-layer YKK zipper, available in standard and XL (220 cm) length.
ST2200
XL Series
XL size, suitable for a single person with a folding chair, or for one adult and a child.
ST701-1001
Sitting & Lying
ST701, ST801, ST901, ST1001 soft-shell options in various sizes for broad use cases.
Hard-Shell Chambers, 304 Stainless Steel, up to 2.0 ATA
In a clinical environment, a hyperbaric chamber must withstand high daily usage and rigorous disinfection. Our hard-shell oxygen chambers, made of SUS304 stainless steel with polycarbonate doors and a multi-layer pressure safety system, are designed for medical clinics and clinical use. They deliver hyperbaric oxygen treatment where hyperbaric healthcare teams expect durable, high-quality hyperbaric equipment that supports faster healing under supervision.
HP1501 / 2202
Monoplace Lying
SUS304 SS, 2.0 ATA pressure, 75/85/90/100 cm diameters. ISO/CE/ASME/RoHS certified.
MC750
Stretcher Style
Sliding side door for incapacitated patients, 1.0-1.6 ATA, built-in 10L/min O2, 8 safety layers.
HE5000 Series
Sitting / Multiplace
SUS304 4.0mm SS, true 2.0 ATA. Includes Mono(1), Fort(1-2), HE5000(2), Plus(4-5 flagship).
DIA-HE5000
Vertical Multi-person
Vertical hard-shell chamber, SUS304 stainless steel, dual-group 280 L/min air supply system.
Model Selection Matrix, match the shell to the buyer
| If your market is… | Recommended line | Pressure | Shell |
|---|---|---|---|
| Home / gym / athletic recovery | ST1700 · L1 · ST2200 | 1.3–1.5 ATA | Soft TPU (SGS) |
| Wellness center / spa clinic | HE5000 Mono / Fort | 2.0 ATA | 304 SS 4.0 mm |
| Hospital / rehab (immobile patients) | MC750 · HP2202 | 1.6–2.0 ATA | 304 SS |
| High-throughput multi-seat clinic | HE5000-PLUS · DIA-HE5000 | 2.0 ATA | 304 SS multi |
Market Insight
Factory-Direct vs. Reseller Markup, What You Actually Pay For
Many of our clients first come to us searching for “hyperbaric chamber manufacturers USA” or the “best hyperbaric chamber” price and discover that bargain imports-those low-cost overseas chambers-have virtually zero resale value. Others are cautioned against bypassing a US distributor, citing potential risks. Our honest advice: verify certification yourself, and the country of origin stops mattering — no trade-off required.
A buyer’s most costly mistake, even when considering a 2-year warranty, is assuming that a lower price means a reduction in quality. This is especially true because our safety features are built to ASME PVHO-1 standards and undergo over 72 hours of rigorous aging tests across six inspection gates. A factory-direct chamber offers the exact same construction as a unit bought through a distributor, but without the intermediary markups. That certified factory standard for ISO 13485 chambers is not adjusted for price; only the markup is. MACY-PAN ships directly to medical and OEM clients, request a factory-direct estimate.
When a client fears an “cheap import,” the underlying concern is that the lower price come at the expense of quality. In fact, most of the difference between the factory price and a US retail store price comes from distribution and retailer margins, not inferior construction.
Buyers often cross-shop a MACY-PAN hyperbaric oxygen chamber against premium hyperbaric names such as Sechrist Industries, HPO TECH, Amron International, or Newtowne Hyperbarics, or a “made in the USA” label. Our honest comparison is standard-for-standard: our advanced hyperbaric builds meet the same ASME PVHO-1 baseline as other leading hyperbaric brands, which is why our hyperbaric solutions rank as highest quality equipment at a factory-direct, high-quality price.
According to third-party market reports, soft-shell chambers are priced around $15,000-$30,000 on average on a US retail shelf, while hard-shell chambers run around $75,000-$200,000+. That same chamber, purchased directly from the factory, eliminates the reseller between the assembly line and your order.
The real cost picture — factory-direct plus operating economics
Independent operators report a single chamber running four to six sessions a day at $100–$500 per session, with annual operating costs near $2,000–$3,000 and full return on investment inside three to six months. Factory-direct pricing shortens that payback by removing the reseller margin, not the build quality.
Every unit still meets ASME PVHO-1:2023 — the FDA-recognized pressure-vessel standard that explicitly names hyperbaric chambers.
Where the money goes, factory-direct vs. distributor path
| Cost layer | Factory-direct (MACY-PAN) | US reseller path |
|---|---|---|
| Chamber build (304 SS / TPU, ASME PVHO-1) | Included at source | Included at source |
| Distributor / storefront margin | None | Added (often the largest line) |
| Warranty & engineering access | Direct to the factory that built it | Through a middleman |
| OEM / color / branding control | Full — Pantone/RAL, logo, packaging | Limited or none |
Safety does not flex with price. Every factory-direct MACY-PAN chamber meets the ASME PVHO-1:2023 standard and is subject to the same six-gate inspection protocol; by going factory-direct, you’re removing only the retailer markup, not the safety standard.
OEM / Wholesale
OEM & Wholesale Manufacturing, Custom Chambers at Your Volume
Distributors’ least favorite OEM risk: long (90+ days) unclear lead times and no OEM communication. Since we own the manufacturing line and engineer systems for you to produce under your brand, color-matched to any Pantone/RAL, and a 230 L/min medical model ships in your voltage. Instead of a trader that rebrands, you can use an ISO 13485 certified factory that controls every OEM step.
Using the manufacturing line allow you to produce our chamber systems under your brand, not ours. We offer paint match for any Pantone/RAL, color/stitch options for interiors, as well as customized branding for packaging, manuals and logos to suit your market.
From a wellness brand launching its first HBOT line to a distributor building a private label product line, your OEM chamber will ship from a single ISO 13485 factory and fall under a single warranty. Full OEM & Wholesale details are available on the OEM page.
The OEM Readiness Checklist, what to confirm before your first PO
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Branding scope Logo placement, custom colors (Pantone/RAL), branded packaging, localized manuals.
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MOQ & tiering Minimum order quantity and volume based pricing suitable for your target market.
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Voltage & language We supply in 110V, 220V, 230V, 240V, and feature a multi-language touch screen interface selected at the time of order.
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Certification fit We match your destination market needs with CE (MDR), ISO 13485, and ASME PVHO-1.
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Lead time & documentation Detailed production schedule, plus export documentation as listed under our Shipping.
SYSTEM // PARTNERSHIP
Distributor & Dealer Program, Partner With the Factory
Simple resale has one weak spot: what if your buyer asks a technical question? While traders have no direct access, our distributor partnership send queries directly to the medical engineers who manufactured the system, for answers across the full 2.0 ATA range, and covers more than the one-year window of a typical resale.
Distributors buy factory hard goods, sell to their customers, and answer questions alone. Partnership with the factory means we stand behind the system’s technical integrity.
01
Territory & margin
We offer established pricing and defined territories that empower you to grow a sustainable HBOT line, rather than sell standalone devices year after year.
02
Engineering-direct support
When your client needs answers, we connect them to the engineers who build our chambers, not an intermediary between you and the factory floor.
03
Full-range catalog
You can offer both soft (1.3 to 1.5 ATA) and hard (2.0 ATA) HBOT models to accommodate the full range of client needs and budgets from a single supplier.
Export & Worldwide Shipping, 126 Countries, Delivered
When your documents or logistics fail, crossing the border may not happen. This happens often after payment and can last for weeks. Since the MACY-PAN export unit has a complete set of documents – a commercial invoice, certificates and manuals for more than 126 countries – a soft shell device can clear customs in as few as 7 days with DHL, and arrive in an inspection-ready state, unlike an untracked shipment, whereas a wooden-crate medical unit stays audit-ready. Reference Incoterms, then request an export estimate with your port.
Overseas sourcing can go wrong if the documentation or logistics break down after the order is paid. Our exports to 126 countries always result in better-than-expected customer reviews of their direct from China delivery experience.
How MACY-PAN ships and documents an order
- 01 Soft-shell: shipped with tracking in a single carton with DHL Express, delivery takes usually 5-7 days around the world.
- 02 Hard-shell: ships in a rugged wooden-crate with protective packaging, specifically for 304 stainless steel systems.
- 03 Compliance Packaging: We are registered for German EPR (VerpackG) and include the necessary CE / RoHS / EMC documentation for smooth EU import.
- 04 Voltage-Ready: chambers are automatically configured to your country’s standard voltage (110V-240V) – no need for a separate transformer.
- 05 Document Set: Each chamber include a commercial invoice, packing list, certificates and manuals, tailored for its destination country.
Our aim is straightforward: your chamber should arrive with certified documents, ready to plug in to your grid, and with proper paperwork to clear your border without issue. Find detailed Incoterms and lead times on our export page.
The 17-Year Manufacturer Scorecard, How to Judge Any HBOT Supplier
Smart buyers evaluate suppliers over a 17-year timeframe and don’t solely base their decisions on price. Because reliable manufacturers operate under auditable standards, our scorecard reflects ISO 13485 certified factory records, a production capacity of 230 L/min, and a history of exports to 126 countries, rather than unsupported claims. Unlike ambiguous vendor statements, each point on our score is verifiable. Request a detailed comparison based on specs.
Verifiable engineering also shows up in the public record: hyperbaric chamber designs appear in patent filings such as US7198045B2, and clinical siting follows facility codes — a single monoplace room needs a minimum 17′ × 7′8″ (5182 × 2337 mm) footprint under NFPA 99. A reliable manufacturer can point to that kind of documentation on request.
“What constitutes a reliable manufacturer of hyperbaric chambers?” – This is the defining question for any discerning buyer. Our scorecard translates this into seven verifiable criteria, showcasing MACY-PAN’s actual standing.
| Criterion | Weak supplier | MACY-PAN |
|---|---|---|
| Years manufacturing | New / rebadged trader | 17 years, own factory |
| Construction standard | No PVHO evidence | ASME PVHO-1:2023 |
| Quality system | None auditable | ISO 13485:2016 + 6 inspection gates |
| Market-access certs | Vague “international” | CE (EU MDR), RoHS, EMC, SGS, TÜV |
| Export footprint | Unproven | 126 countries |
| OEM capability | Fixed catalog only | Full Pantone/RAL + private label |
| Support model | Middleman only | Factory-direct engineering access |
Clinical & Engineering Evaluation Tools
Access our specialized interactive modules to verify compliance standards, configure exact equipment specifications, and evaluate manufacturing readiness.
Frequently Asked Questions
Over a 17-year purchase cycle, the most costly error is overlooking certificate verification. Each response to these questions is grounded in a ISO 13485 certified factory document, unlike most FAQ pages which offer generic marketing. Unlike un substantiated statements, our answers correlate with a traceable medical audit trail.
Look for a construction-safety standard (ASME PVHO-1 for pressure vessels for human occupancy) plus a quality-management system (ISO 13485) and the market-access certification your region requires (CE under EU MDR in Europe, FDA 510(k) in the US). MACY-PAN holds ISO 13485:2016, CE (EU MDR 2017/745), ASME PVHO-1:2023, RoHS, EMC, and SGS material reports.
No, MACY-PAN is not FDA 510(k) cleared, and we say so plainly.
Safety depends on the standards a chamber is built and stamped to, not the country of origin. MACY-PAN builds every hard-shell chamber to ASME PVHO-1:2023, the same human-occupancy pressure vessel standard that the US Navy mandates for diving operations and that leading American manufacturers such as Perry Baromedical stamp on their own chambers. The build runs under an ISO 13485 quality management system with six sequential factory inspection gates: raw-material inspection, assembly test, a 72-hour aging test, full-system test, final inspection, and packing inspection. The country on the label does not set the safety floor; the standard the chamber is certified and stamped to does, and every one of those certificates is documented and independently verifiable before you place an order.
Soft-shell (mild) chambers use SGS-certified medical TPU and run at 1.3–1.5 ATA, ideal for home wellness and athletic recovery. Hard-shell chambers use 304 stainless steel and reach 2.0 ATA for clinical and hospital settings. MACY-PAN manufactures both lines, so one supplier covers your full range.
Lead time depends on model, configuration, and order volume, and OEM branding (Pantone/RAL color, logo, packaging, localized manuals) is available with a minimum order quantity. Soft-shell units typically ship by DHL in 5–7 days once produced; hard-shell systems ship in protective wooden crates. Request the OEM catalog for current MOQ and scheduling.
Ask for the certificate documents up front and match each one against what it actually governs, a supplier that hesitates is a red flag. MACY-PAN sends its full Certification Pack (ISO 13485, CE, ASME PVHO-1, RoHS, EMC, SGS) before purchase, and our Certification Decoder table above shows what each standard proves.
Factory Selection Support
Need a hyperbaric chamber matched to your room, pressure target, and compliance documents?
MACY-PAN helps clinics, wellness centers, distributors, and home buyers compare soft-shell, hard-shell sitting, and medical-grade lying chambers before quotation. Send your intended use, available space, country, and preferred ATA range, and our team will recommend a practical model path.
2007HBOT manufacturing since
126+countries shipped to
1.3-2.0ATA chamber range
