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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, For Muscle Conditioning
510(k) Number K062439
Device Name POWERTONE, MODEL PT-11
Applicant
Johari Digital Healthcare , Ltd.
26540 W. Agoura Rd.
Suite 230
Calabases,  CA  91302
Applicant Contact NISHA JOHARI
Correspondent
Johari Digital Healthcare , Ltd.
26540 W. Agoura Rd.
Suite 230
Calabases,  CA  91302
Correspondent Contact NISHA JOHARI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/21/2006
Decision Date 01/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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