Chamber, Hyperbaric
Anesthesiology · 21 CFR 868.5470
Recent MDR events
153 adverse event reports on file
- HYPERBARIC OXYGEN THERAPYJul 10, 2026InjuryUnkMW5190603
- SECHRIST INDUSTRIES INC.Jul 9, 2026MalfunctionSechrist Industries2020676-2026-00008
- SECHRIST INDUSTRIES INCJul 2, 2026MalfunctionSechrist Industries2020676-2026-00007
- TROJAN HYPERBARIC CHAMBERMay 12, 2026InjuryHpo TechMW5188057
- SECHRIST INDUSTRIES INC.May 5, 2026InjurySechrist Industries Inc.2020676-2026-00006
- SECHRIST INDUSTRIES INC.Apr 8, 2026InjurySechrist Industries Inc.2020676-2026-00005
- SECHRIST INDUSTRIES INC.Mar 23, 2026MalfunctionSechrist Industries Inc.2020676-2026-00003
- VITAERIS 320 HYPERBARIC OXYGEN CHAMBERMar 23, 2026InjuryOxyhealth, LlcMW5185604
- SECHRIST INDUSTIESJan 12, 2026MalfunctionSechrist Industries2020676-2026-00002
- PERRYDec 5, 2025MalfunctionPerry Baromedical Corporation23728558
Event type breakdown
Recalls
3 recall events for this product code
- Baro-Therapies, IncTerminatedSep 30, 2014
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc.
The firm is distributing the Rejuvenator device without an approved 510(k).
Z-2734-2014 · View FDA record ↗ - Sechrist Industries IncTerminatedNov 6, 2012
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER
Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Z-0208-2013 · View FDA record ↗ - Sechrist Industries IncTerminatedNov 6, 2012
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER
Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Z-0209-2013 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Us Hyperbaric Network Llc
Sunrise, FL, US
Aha Hyperbarics Gmbh
Vienna Wien, AT
Perry Baromedical Corporation
Riviera Beach, FL, US
Hyperbaric For Life Llc
Waddell, AZ, US
Fink Engineering Pty Ltd
Laverton North Victoria, AU
Typhoon Water Wares
Pocomoke City, MD, US
Summit To Sea, Llc.
Mound, MN, US
Pcci, Inc
ALEXANDRIA, VA, US
Tekna Manufacturing Pvt. Ltd.
Chennai Tamil Nadu, IN
Oxavita S.r.l.
Buenos Aires, AR
Tribalco
Tampa, FL, US
Hyperbaric Modular Systems, Inc.
San Diego, CA, US
Sea-long Medical Systems, Llc
Waxahachie, TX, US
Hyperbaric Technologies, Inc.
Amsterdam, NY, US
510(k) clearances
69 clearances for this product code
- Fink Engineering Pty, Ltd.Nov 21, 2024
K240569 · FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
- Us Hyperbaric NetworkMay 4, 2023
K220290 · Revitalair 430+
- Oxavita SrlNov 22, 2019
K171899 · Revitalair 430F
- Oxyheal Medical Systems, Inc.Mar 22, 2017
K163109 · OxyHeal 4000 Multiplace Hyperbaric Chamber Family
- Oxyheal Medical Systems, Inc.Apr 29, 2016
K152223 · Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
- Sechrist Industries, Inc.May 30, 2014
K140559 · SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
- Reimers Systems, Inc.Aug 19, 2011
K102831 · RSI 4200
- Environmental Tectonics Corp.Aug 13, 2010
K092991 · O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)