Cleared Traditional

PEDAL EXERCISER

K832968 · Maddak, Inc. · Physical Medicine
Sep 1983
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K832968 is an FDA 510(k) clearance for the PEDAL EXERCISER, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Maddak, Inc. (Walker, US). The FDA issued a Cleared decision on September 29, 1983, 28 days after receiving the submission on September 1, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K832968 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1983
Decision Date September 29, 1983
Days to Decision 28 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