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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 K011588
Device Name SURETONE
Applicant
Suretone International
2 Presedent Brand St.
Panorama
Cape Town, Cape,  ZA 7500
Applicant Contact MARYNA BURKE
Correspondent
Suretone International
2 Presedent Brand St.
Panorama
Cape Town, Cape,  ZA 7500
Correspondent Contact MARYNA BURKE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/23/2001
Decision Date 03/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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