510(k) K102190
K102190 is an FDA 510(k) premarket notification submitted by Johari Digital Healthcare , Ltd. for the device "WINSTIM". The FDA issued a decision of Substantially Equivalent on March 17, 2011. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Johari Digital Healthcare , Ltd. has at least 6 other 510(k) clearances on record.
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