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HMS-5000

Hyperbaric Modular Systems Inc. · Model HMS-5000-12-COMPACT-QUADRO · UDI-DI 00860006478919

CBF Prescription

510(k) clearances

154

Adverse events (12 deaths)

Recalls

Facilities

Description

The HMS-5000-12-COMPACT-QUADRO is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments which are pressurized with air used for administering hyperbaric oxygen therapy treatments up to twelve (12) patients simultaneously at a pressure up to 3 atmospheres absolute (3ATA). It is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.

Recalls

Date	Firm	Reason
2014-08-08	Baro-Therapies, Inc	The firm is distributing the Rejuvenator device without an approved 510(k).
2008-08-28	Sechrist Industries Inc	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 perform
2008-08-28	Sechrist Industries Inc	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 perform

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.