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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
510(k) Number K102190
Device Name WINSTIM
Applicant
JOHARI DIGITAL HEALTHCARE, LTD.
G-582,583, E.P.I.P.
BORANADA
JODHPUR ,RAJASTHAN,  IN 342008
Applicant Contact NISHA JOHARI
Correspondent
JOHARI DIGITAL HEALTHCARE, LTD.
G-582,583, E.P.I.P.
BORANADA
JODHPUR ,RAJASTHAN,  IN 342008
Correspondent Contact NISHA JOHARI
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZI   GZJ   IPF  
Date Received08/03/2010
Decision Date 03/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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