Cleared Traditional

FITNESS

K833249 · Fitness Equipment Co., Inc. · Physical Medicine
Nov 1983
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K833249 is an FDA 510(k) clearance for the FITNESS, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Fitness Equipment Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 7, 1983, 45 days after receiving the submission on September 23, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K833249 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1983
Decision Date November 07, 1983
Days to Decision 45 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