Cleared Traditional

SUPPORT VEST

K963459 · Skil-Care Corp. · Physical Medicine
Oct 1996
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K963459 is an FDA 510(k) clearance for the SUPPORT VEST, a Restraint, Wheelchair, Non-protective (Class I — General Controls, product code KID), submitted by Skil-Care Corp. (Yonkers, US). The FDA issued a Cleared decision on October 15, 1996, 42 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 K963459 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1996
Decision Date October 15, 1996
Days to Decision 42 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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