Clearance Summary
Wheelchair received FDA 510(k) clearance under submission number K163352, sponsored by Kunshan Hi-Fortune Health Products 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 2017-07-28.
- Submission: K163352
- Applicant / Sponsor: Kunshan Hi-Fortune Health Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2017-07-28
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.