510(k) K032669
- Device
- Y.E.S. POWERED WHEELCHAIR, MODEL T200
- Applicant
- Yeou Eir Shuen Machinery Co., Ltd.
- 510(k) number
- K032669
- Product code
- ITN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-12
- Date received
- 2003-08-28
- Regulation
- 890.3675
- Classification name
- Splint, Denis Brown
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ke-Min Jen
- Address
- # 58, Fu-Chiun St. Hsin-Chu City TW
FDA Registration Numbers#
- 3013680140
- 3003898328
- 8040278
- 3000146561
- 3011564321
- 3011658802
- 1051118
- 1058152
- 3011497619
- 1022826
- 2950684
- 1824252
- 3005841961
- 3005663580
Source Documents#
510(k) summary PDF not indicated by FDA