Clearance Summary
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR received FDA 510(k) clearance under submission number K112948, sponsored by Jiangsu Healthy Way Medical Equipment 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 2012-03-28.
- Submission: K112948
- Applicant / Sponsor: Jiangsu Healthy Way Medical Equipment Co;Ltd
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2012-03-28
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.