Clearance Summary
18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR received FDA 510(k) clearance under submission number K094047, sponsored by Modern Rehabilitation Solutions 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 2010-03-22.
- Submission: K094047
- Applicant / Sponsor: Modern Rehabilitation Solutions Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2010-03-22
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.