FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
Y.E.S. POWERED WHEELCHAIR, MODEL T200
K Number: K032669
·
Decision Nov 12, 2003
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
2
Applicant Total
2
Review Days
76
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Basic Information
- Device Name
- Y.E.S. POWERED WHEELCHAIR, MODEL T200
- K Number
- K032669
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3675
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Yeou Eir Shuen Machinery Co., Ltd.
- Date Received
- August 28, 2003
- Decision Date
- November 12, 2003
- Product Code
- ITN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITN | Splint, Denis Brown | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITN), ordered by most recent decision date.
VIEWMATE SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
COUNTER-ROTATION SYSTEM
FDA 510(k)
FDA Class 1
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Other Clearances by Yeou Eir Shuen Machinery Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K032512 | Y.E.S POWERED WHEELCHAIR. T180 | Nov 12, 2003 | Substantially Equivalent |