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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 K950783
Device Name 4000+
Applicant
U.S. Therapy Products, Inc.
4600 W. 77th
Suite 106
Edina,  MN  55435
Applicant Contact JACK BAUMGARTEN
Correspondent
U.S. Therapy Products, Inc.
4600 W. 77th
Suite 106
Edina,  MN  55435
Correspondent Contact JACK BAUMGARTEN
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received02/21/1995
Decision Date 10/27/1995
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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