Cleared Traditional

GEL-T CUSHION

K960189 · Span-America Medical Systems, Inc. · Physical Medicine
Feb 1996
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K960189 is an FDA 510(k) clearance for the GEL-T CUSHION, a Cushion, Flotation (Class I — General Controls, product code KIC), submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on February 7, 1996, 22 days after receiving the submission on January 16, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3175.

Submission Details

510(k) Number K960189 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1996
Decision Date February 07, 1996
Days to Decision 22 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code KIC — Cushion, Flotation
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3175