Clearance Summary
NISSIN PEDIATRIC SERIES WHEELCHAIR received FDA 510(k) clearance under submission number K063521, sponsored by Nissin Medical, Inc.. 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 2007-02-05.
- Submission: K063521
- Applicant / Sponsor: Nissin Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3100
- Decision date: 2007-02-05
Classification & Regulation
This clearance is catalogued under FDA product code INM and 21 CFR 890.3100, within the Physical Medicine review panel as a Class I device.