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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K933611
Device Name THE BTE WS30
Applicant
Baltimore Therapeutic Equipment Co.
7455 L New Ridge Rd.
Hanover,  MD  21076
Applicant Contact JOHN VERMETTE
Correspondent
Baltimore Therapeutic Equipment Co.
7455 L New Ridge Rd.
Hanover,  MD  21076
Correspondent Contact JOHN VERMETTE
Regulation Number890.5360
Classification Product Code
ISD  
Date Received07/19/1993
Decision Date 06/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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