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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 K864558
Device Name U66 EMS
Applicant
Suntec Health & Fitness Group, Inc.
Crystal Tree Plz.
1201 Us One
North Palm Beach,  FL  33408
Applicant Contact MAGNUS AHLEN
Correspondent
Suntec Health & Fitness Group, Inc.
Crystal Tree Plz.
1201 Us One
North Palm Beach,  FL  33408
Correspondent Contact MAGNUS AHLEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/31/1986
Decision Date 12/29/1986
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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