Cleared Traditional

PONCHO VEST RESTRAINT

K963475 · Deroyal Industries, Inc. · Physical Medicine
Jan 1997
Decision
141d
Days
Class 1
Risk

About This 510(k) Submission

K963475 is an FDA 510(k) clearance for the PONCHO VEST RESTRAINT, a Restraint, Wheelchair, Non-protective (Class I — General Controls, product code KID), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on January 22, 1997, 141 days after receiving the submission on September 3, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3910.

Submission Details

510(k) Number K963475 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1996
Decision Date January 22, 1997
Days to Decision 141 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code KID — Restraint, Wheelchair, Non-protective
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3910

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