Cleared Traditional

MOTORIZED PARALLEL BAR, MODEL 110

K882916 · Tri W-G, Inc. · Physical Medicine
Jul 1988
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K882916 is an FDA 510(k) clearance for the MOTORIZED PARALLEL BAR, MODEL 110, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on July 28, 1988, 16 days after receiving the submission on July 12, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K882916 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1988
Decision Date July 28, 1988
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code BXB — Exerciser, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5380