Cleared Traditional

BRACE C.T.

K831310 · Innovation Sports, Inc. · Physical Medicine

May 1983

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K831310 is an FDA 510(k) clearance for the BRACE C.T., a Joint, Knee, External Brace (Class I — General Controls, product code ITQ), submitted by Innovation Sports, Inc. (Walker, US). The FDA issued a Cleared decision on May 16, 1983, 24 days after receiving the submission on April 22, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number	K831310 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1983
Decision Date	May 16, 1983
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—