Cleared Traditional

R1361 & R1372 MEASURED EXERCISE EQUIPMENT

K861348 · Tri W-G, Inc. · Physical Medicine
May 1986
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K861348 is an FDA 510(k) clearance for the R1361 & R1372 MEASURED EXERCISE EQUIPMENT, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on May 2, 1986, 25 days after receiving the submission on April 7, 1986. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K861348 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1986
Decision Date May 02, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ISD — Exerciser, Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5360

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