Cleared Traditional

DELUXE KNEE IMMOBILIZER

K823159 · Warm & Form, Orthopedic Materials · Physical Medicine
Nov 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K823159 is an FDA 510(k) clearance for the DELUXE KNEE IMMOBILIZER, a Joint, Knee, External Brace (Class I — General Controls, product code ITQ), submitted by Warm & Form, Orthopedic Materials (Mchenry, US). The FDA issued a Cleared decision on November 10, 1982, 16 days after receiving the submission on October 25, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K823159 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1982
Decision Date November 10, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ITQ — Joint, Knee, External Brace
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475

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