Cleared Traditional

TRUNCAL ORTHOSIS

K821682 · Surgical Appliance Industries, Inc. · Physical Medicine
Jun 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K821682 is an FDA 510(k) clearance for the TRUNCAL ORTHOSIS, a Orthosis, Lumbar (Class I — General Controls, product code IQE), submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982, 16 days after receiving the submission on June 8, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3490.

Submission Details

510(k) Number K821682 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1982
Decision Date June 24, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IQE — Orthosis, Lumbar
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3490