Cleared Traditional

CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM

K962788 · Gaymar Industries, Inc. · Physical Medicine
Apr 1997
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K962788 is an FDA 510(k) clearance for the CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM, a Bed, Patient Rotation, Powered (Class II — Special Controls, product code IKZ), submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on April 30, 1997, 287 days after receiving the submission on July 17, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5225.

Submission Details

510(k) Number K962788 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1996
Decision Date April 30, 1997
Days to Decision 287 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IKZ — Bed, Patient Rotation, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5225

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