Cleared Traditional

THE BTE WS30

K933611 · Baltimore Therapeutic Equipment Co. · Physical Medicine
Jun 1994
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K933611 is an FDA 510(k) clearance for the THE BTE WS30, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on June 20, 1994, 336 days after receiving the submission on July 19, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K933611 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1993
Decision Date June 20, 1994
Days to Decision 336 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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

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