FDA Disclaimer-Hyperbaric-Oxyrevo

OxyRevo hyperbaric chambers: certifications and FDA compliance

Here is exactly how OxyRevo equipment fits within U.S. and international standards, followed by the full list of manufacturer certification and test documents behind every chamber we sell.

FDA STATUS

OxyRevo chambers are CE certified and UKCA verified, but not FDA cleared for medical use in the United States. They are designed for wellness and recovery applications. If you need an FDA cleared chamber, call us and we will point you to the models that carry that clearance.

Full FDA and medical disclaimer

The FDA clears soft chambers only up to 1.3 ATA for altitude sickness. Using any chamber for wellness or recovery is off-label use: legal, but not FDA evaluated. Chambers at 1.4 to 2.0 ATA are typically Class II devices requiring a prescription and PVHO-1 compliance in the U.S.

Unless stated for an FDA cleared product, the FDA has not evaluated products or statements on RecovAthlete.com, our products do not diagnose, treat, cure, or prevent any disease, and all content is educational only. Consult a licensed provider before use, especially if you are pregnant, managing a medical condition, or taking prescription medication.

Results vary and are not guaranteed. RecovAthlete and its affiliates are not liable for injury, harm, or adverse effects from the use or misuse of our products, and users assume full responsibility for product use.

Every OxyRevo chamber we sell is CE certified and UKCA verified

OxyRevo chambers are made by Zhuji Belecon Health Technology Co., Ltd. The manufacturer holds 21 certification and test documents covering the chambers, compressors, tanks and inflatable bags. RecovAthlete has been an authorized OxyRevo dealer since 2023 and sells 11 models in the US. Certificates are issued to the manufacturer and cover the full range, including models we do not stock.

CE certification (issued by Ente Certificazione Macchine, Italy) covers European machinery, electrical and pressure equipment safety rules. UKCA verification (ICR Polska) covers the equivalent UK regulations. ISO 13485:2016 is the medical-device quality standard. EMC testing confirms no interference with home electronics, and RoHS and REACH testing confirms the foam, seals and fabric contain no restricted chemicals.

The full documents are grouped below. Click any section to open its table.

1. CE certificates and verifications (4 documents)
# Type Certificate no. Product and models Associated TCF / test report no. CE directive Standards verified Issued Expires
1 CE Certificate 0P230407.ZBHUW55 Oil free air compressor and air pump. AE01 to AE08, AP01 to AP08, O2ILS14, O2ILS15, O2ILH15, O2ILH16, O2ILH18, O2ILH20 MD-TCF-230407-45790
TEZJ23040745791		 2006/42/EC Machinery
2014/35/EU Low Voltage
2014/30/EU EMC		 EN ISO 12100:2010, EN 60204-1:2018, EN 1012-1:2010, EN IEC 61000-6-2:2019, EN IEC 61000-6-4:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 07 Apr 2023 06 Apr 2028
2 CE Verification 0P230407.ZBHUW53 Stainless steel tank. Quest 30 to Quest 90 Pro, Space series, Delux Pod, Delux Combo, Delux Pro, O2ILH, O2ILM, O2IL Pro, O2IL Fly series TPZJ23040745788 2014/68/EU Pressure Equipment EN 12953-1:2012, EN 14222:2021 07 Apr 2023 06 Apr 2028
3 CE Certificate 0P230407.ZBHUW56 Air refrigerator dryer (dehumidifier). ZLA01 to ZLA06, LQ01 to LQ06 MD-TCF-230407-45792
TEZJ23040745793		 2006/42/EC Machinery
2014/35/EU Low Voltage
2014/30/EU EMC		 EN ISO 12100:2010, EN 60204-1:2018, EN IEC 61000-6-2:2019, EN IEC 61000-6-4:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 07 Apr 2023 06 Apr 2028
4 CE Attestation 0P230407.ZBHUW54 Inflatable bag. Elite, Apex, Forward, Heal, Heal Multi, OXY, O2ILS series TGZJ23040745789 2001/95/EC General Product Safety EN ISO 23537-1:2016+A1:2018, EN ISO 23537-2:2016 07 Apr 2023 06 Apr 2028

Issued by Ente Certificazione Macchine (ECM), Italy, under a voluntary non-notified procedure per European Commission note of 14 September 2022, Ares(2022)6342894. These documents support the EC Declaration of Conformity, they do not replace it.

2. UKCA verifications of conformity (6 documents)
# Certificate no. Serial no. Product Models UK regulation Standards Issued Expires
5 ICR/VC/HM2503215 013434 Air dehumidifier ZLA01 to ZLA08, LQ01 to LQ08 Electrical Equipment (Safety) Regulations 2016
EMC Regulations 2016		 BS EN IEC 60335-1:2023+A11:2023, BS EN IEC 55014-1:2021, EN IEC 55014-2:2021, BS EN IEC 61000-3-2:2019+A1:2021, BS EN 61000-3-3:2013+A2:2021 26 Mar 2025 25 Mar 2030
6 ICR/VC/HM2503216 013435 Hyperbaric chamber Elite and Apex 28, 32, 36, 40. Forward90. Heal40 to Heal90. Quest30 to Quest36. Space60 to Space90. House H1 to H9. Silo S1 to S9. Relax R1 to R9. Monoplace, Multiplace, Pro, Pod, 01 to 06. O2ILH, O2ILM, O2IL Pro, O2IL Fly 75, 80, 86, 90 Pressure Equipment (Safety) Regulations 2016 BS EN 13445-1:2021 26 Mar 2025 25 Mar 2030
7 ICR/VC/HM2503217 013436 Inflatable bag Elite and Apex 28, 32, 36, 40. Forward90. Heal40 to Heal90 General Product Safety Regulations 2005 BS EN ISO 23537-1:2022 26 Mar 2025 25 Mar 2030
8 ICR/VC/HM2503218 013437 Oil free air compressor and air pump AE01 to AE09, AP01 to AP09, O2ILS14, O2ILS15, O2ILH15, O2ILH16, O2ILH18, O2ILH20 Supply of Machinery (Safety) Regulations 2008 BS EN ISO 12100:2010, BS EN 60204-1:2018 26 Mar 2025 25 Mar 2030
9 ICR/VC/HM2503219 013438 Rest pod Quest30 to Quest36. Space60 to Space90. House H1 to H9. Silo S1 to S9. Relax R1 to R9. Monoplace, Multiplace, Pro, Pod, 01 to 06. O2ILH, O2ILM, O2IL Pro, O2IL Fly 75, 80, 86, 90 Pressure Equipment (Safety) Regulations 2016 BS EN 13445-1:2021 26 Mar 2025 25 Mar 2030
10 ICR/VC/HM2503220 013439 Stainless steel tank Quest30 to Quest36. Space60 to Space90. House H1 to H9. Silo S1 to S9. Relax R1 to R9. Monoplace, Multiplace, Pro, Pod, 01 to 06. O2ILH, O2ILM, O2IL Pro, O2IL Fly 75, 80, 86, 90 Pressure Equipment (Safety) Regulations 2016 BS EN 13445-1:2021 26 Mar 2025 25 Mar 2030

Issued by ICR Polska Co. Ltd. on a voluntary basis. The manufacturer applies the UKCA mark after meeting all essential requirements of the relevant UK regulations.

3. ISO quality management certificate (1 document)
# Certificate no. Standard Scope Issuing body Issued Registered Expires
11 AKAQMSMD000884 ISO 13485:2016 Sales of hyperbaric oxygen chambers and related accessories Jiangsu AKA International Standard Certification Co., Ltd. 08 Dec 2023 07 Dec 2023 06 Dec 2026
4. Technical construction files and MD/LVD reports (3 documents)
# Type File / report no. Product Models Prepared by Directive Standards covered Date
12 TCF / MD+LVD MD-TCF-230407-45790 Oil free air compressor and air pump AE01 to AE08, AP01 to AP08, O2ILS14, O2ILS15, O2ILH15, O2ILH16, O2ILH18, O2ILH20 Shanghai Global Testing Services (GTS) 2006/42/EC Machinery
2014/35/EU Low Voltage		 EN ISO 12100, EN 1012-1, EN 60204-1 06 Apr 2023
13 TCF / MD+LVD MD-TCF-230407-45792 Air refrigerator dryer (dehumidifier) ZLA01 to ZLA06, LQ01 to LQ06 Shanghai Global Testing Services (GTS) 2006/42/EC Machinery
2014/35/EU Low Voltage		 EN ISO 12100, EN 60204-1 06 Apr 2023
14 TCF TGZJ23040745789 Inflatable bag Elite, Apex, Forward, Heal, Heal Multi, OXY, O2ILS series Shanghai Global Testing Services (GTS) 2001/95/EC General Product Safety EN ISO 23537-1:2016+A1:2018, EN ISO 23537-2:2016 06 Apr 2023
5. Risk assessment reports (2 documents)
# File no. Product Models Prepared by Directive Date
15 MD-TCF-230407-45790 Oil free air compressor and air pump AE01 to AE08, AP01 to AP08, O2ILS14, O2ILS15, O2ILH15, O2ILH16, O2ILH18, O2ILH20 Shanghai Global Testing Services (GTS) 2006/42/EC Machinery Directive 06 Apr 2023
16 MD-TCF-230407-45792
filed as MD-TCF-220510-38556 		Air refrigerator dryer (dehumidifier) ZLA01 to ZLA06, LQ01 to LQ06 Shanghai Global Testing Services (GTS) 2006/42/EC Machinery Directive 06 Apr 2023
6. EMC technical files (2 documents, both PASS)
# Report no. Product Models Prepared by Standards Result Date
17 TEZJ23040745791 Oil free air compressor and air pump AE01 to AE08, AP01 to AP08, O2ILS14, O2ILS15, O2ILH15, O2ILH16, O2ILH18, O2ILH20 Shanghai Global Testing Services (GTS) EN IEC 61000-6-4:2019, EN IEC 61000-6-2:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 PASS 06 Apr 2023
18 TEZJ23040745793 Air refrigerator dryer ZLA-01 to ZLA-06 Shanghai Global Testing Services (GTS) EN IEC 61000-6-4:2019, EN IEC 61000-6-2:2019, EN IEC 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 PASS 06 Apr 2023
7. Material and chemical test reports (3 documents, all PASS)
# Test Report no. Sample and material Test framework Testing lab Sample received Report date Result
19 RoHS Test SHAEC2110662211 Mattress sponge (square sponge, white foam) RoHS Directive (EU) 2015/863 amending Annex II to 2011/65/EU. IEC 62321 series SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd 27 May 2021 01 Jun 2021 PASS
20 SVHC / REACH CZXHL23002411601 Silicone seal strip (grey soft plastic) REACH. 235 SVHC candidate list substances (ECHA, to Jun 2023). SVHC limit 0.1% by weight SGS-CSTC Standards Technical Services (Changzhou) Co., Ltd 27 Dec 2023 05 Jan 2024 PASS
21 SVHC / REACH CZXHL23002180601 TPU composite fabric REACH. 235 SVHC candidate list substances (ECHA, to Jun 2023). SVHC limit 0.1% by weight SGS-CSTC Standards Technical Services (Changzhou) Co., Ltd 24 Nov 2023 04 Dec 2023 PASS

The 11 OxyRevo models we carry

Every model below sits inside the certified scope of the chamber, tank, bag and compressor documents above.

QUESTIONS ABOUT CERTIFICATION OR FDA STATUS

Call 866-861-6317, 9am to 6pm EST, Monday to Friday, or email support@recovathlete.com. You can also book a 30 minute call. We can also request certificate copies from OxyRevo for any model you name.

Browse the full OxyRevo range or compare across brands in hyperbaric chambers.