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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K863383
Device Name FACIAL MASSAGER, BATTERY POWERED
Applicant
GENERAL PHYSIOTHERAPY, INC.
1520 WASHINGTON AVE.
ST. LOUIS,  MO  63103
Applicant Contact JAMES M BIGGINS
Correspondent
GENERAL PHYSIOTHERAPY, INC.
1520 WASHINGTON AVE.
ST. LOUIS,  MO  63103
Correspondent Contact JAMES M BIGGINS
Regulation Number890.5660
Classification Product Code
ISA  
Date Received09/03/1986
Decision Date 09/15/1986
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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