Clearance Summary
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P received FDA 510(k) clearance under submission number K052586, sponsored by Taiwan an I 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 2005-12-09.
- Submission: K052586
- Applicant / Sponsor: Taiwan an I Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2005-12-09
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.