Cleared Traditional

CUSTOMCARE SEATING SYSTEM

K954117 · Span-America Medical Systems, Inc. · Physical Medicine
Oct 1995
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K954117 is an FDA 510(k) clearance for the CUSTOMCARE SEATING SYSTEM, 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 October 13, 1995, 42 days after receiving the submission on September 1, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3175.

Submission Details

510(k) Number K954117 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1995
Decision Date October 13, 1995
Days to Decision 42 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