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TEKNA Manufacturing Pvt. Ltd.

TEKNA MANUFACTURING PRIVATE LIMITED · Model Modular Rectangular 6000 0 6 0 2 D/L · UDI-DI 08906124945505

CBF Prescription

510(k) clearances

154

Adverse events (12 deaths)

Recalls

Facilities

Description

Modular Multiplace hyperbaric chamber consisting of ASME 'U' stamped pressure vessel that can accommodate 6 patients in the main lock and 2 patients in the entry lock and a control console for the same. The entire system is ASME PVHO-1 compliant.

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.