Clearance Summary
Power Wheelchair (JJW-6001) received FDA 510(k) clearance under submission number K240563, sponsored by ZheJiang J&J Mobility 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 2024-10-08.
- Submission: K240563
- Applicant / Sponsor: ZheJiang J&J Mobility Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2024-10-08
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.