Cleared Traditional

SAFETY PONCHO/SHOULDER STRAP PONCHO

K963461 · Skil-Care Corp. · Physical Medicine
Oct 1996
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K963461 is an FDA 510(k) clearance for the SAFETY PONCHO/SHOULDER STRAP PONCHO, 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 11, 1996, 38 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 K963461 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1996
Decision Date October 11, 1996
Days to Decision 38 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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