Clearance Summary
GUO GUANG WHEEL CHAIR received FDA 510(k) clearance under submission number K870043, sponsored by China National Medicines & Health Prod. I/E Corp.. 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 1987-01-28.
- Submission: K870043
- Applicant / Sponsor: China National Medicines & Health Prod. I/E Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1987-01-28
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.