Clearance Summary
Manual Wheelchair SIVFH2A102 received FDA 510(k) clearance under submission number K190534, sponsored by Jiangsu Horizon Medical Science & Technology 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 2019-05-29.
- Submission: K190534
- Applicant / Sponsor: Jiangsu Horizon Medical Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2019-05-29
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.