Cleared Traditional

ARM CUSHION

K830427 · Maddak, Inc. · Physical Medicine
Mar 1983
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K830427 is an FDA 510(k) clearance for the ARM CUSHION, a Cushion, Flotation (Class I — General Controls, product code KIC), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983, 48 days after receiving the submission on February 9, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3175.

Submission Details

510(k) Number K830427 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1983
Decision Date March 29, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

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