Cleared Traditional

KNEE WALKER

K833870 · Maddak, Inc. · Physical Medicine
Nov 1983
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K833870 is an FDA 510(k) clearance for the KNEE WALKER, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1983, 21 days after receiving the submission on November 8, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K833870 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1983
Decision Date November 29, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ION — Exerciser, Non-measuring
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5370