Clearance Summary
QK-SYSTEMIC THERAPEUTIC APPARATUS received FDA 510(k) clearance under submission number K141892, sponsored by Harbin Quanke Medi-Technical Development Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2015-01-28.
- Submission: K141892
- Applicant / Sponsor: Harbin Quanke Medi-Technical Development Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2015-01-28
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.