Cleared Traditional

SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL

K963455 · Skil-Care Corp. · Physical Medicine
Oct 1996
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K963455 is an FDA 510(k) clearance for the SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL, 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 8, 1996, 35 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 K963455 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1996
Decision Date October 08, 1996
Days to Decision 35 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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