Clearance Summary
Y.E.S. POWERED WHEELCHAIR, MODEL T200 received FDA 510(k) clearance under submission number K032669, sponsored by Yeou Eir Shuen Machinery 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 2003-11-12.
- Submission: K032669
- Applicant / Sponsor: Yeou Eir Shuen Machinery Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3675
- Decision date: 2003-11-12
Classification & Regulation
This clearance is catalogued under FDA product code ITN and 21 CFR 890.3675, within the Physical Medicine review panel as a Class I device.