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PAHI PAH-S1 Monoplace Hyperbaric Chamber

PAN-AMERICA HYPERBARICS INC. · Model PAH-S1 · UDI-DI 04719872000013

CBF Prescription

510(k) clearances

153

Adverse events (12 deaths)

Recalls

Facilities

Description

The PAH-SI Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses 100% oxygen as the pressurization gas and patient breathes the oxygen contained inside the chamber as the hyperbaric treatment gas.

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.