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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K940301
Device Name COMPEX 2
Applicant
Biodex Medical Systems, Inc.
Brookhaven R & D Plz.
20 Ramsey Rd., P.O. Box 702
Shirley,  NY  11967
Applicant Contact CLYDE SCHEIN
Correspondent
Biodex Medical Systems, Inc.
Brookhaven R & D Plz.
20 Ramsey Rd., P.O. Box 702
Shirley,  NY  11967
Correspondent Contact CLYDE SCHEIN
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received01/24/1994
Decision Date 12/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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