Clearance Summary
WINSTIM received FDA 510(k) clearance under submission number K102190, sponsored by Johari Digital Healthcare , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2011-03-17.
- Submission: K102190
- Applicant / Sponsor: Johari Digital Healthcare , Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5860
- Decision date: 2011-03-17
Classification & Regulation
This clearance is catalogued under FDA product code IMG and 21 CFR 890.5860, within the Physical Medicine review panel as a Class II device.