Clearance Summary
COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) received FDA 510(k) clearance under submission number K100656, sponsored by Wonjin Mulsan Co., 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 2010-05-26.
- Submission: K100656
- Applicant / Sponsor: Wonjin Mulsan Co., Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2010-05-26
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.