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510(k) K102190

WINSTIM by Johari Digital Healthcare , Ltd. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2011
Date Received
August 3, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

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