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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K924414
Device Name THE BTE DYNAMIC LIFT
Applicant
Baltimore Therapeutic Equipment Co.
7455-L New Ridge Rd.
Hanover,  MD  21076
Applicant Contact CARL R LUNDBLAD
Correspondent
Baltimore Therapeutic Equipment Co.
7455-L New Ridge Rd.
Hanover,  MD  21076
Correspondent Contact CARL R LUNDBLAD
Regulation Number890.1925
Classification Product Code
IKK  
Date Received08/31/1992
Decision Date 02/12/1993
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
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