Cleared Traditional

DELUXE KNEE IMMOBILIZER(UNIVERSAL)

K823658 · Warm & Form, Orthopedic Materials · Physical Medicine

Dec 1982

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K823658 is an FDA 510(k) clearance for the DELUXE KNEE IMMOBILIZER(UNIVERSAL), a Joint, Knee, External Brace (Class I — General Controls, product code ITQ), submitted by Warm & Form, Orthopedic Materials (Walker, US). The FDA issued a Cleared decision on December 30, 1982, 24 days after receiving the submission on December 6, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number	K823658 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 1982
Decision Date	December 30, 1982
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—