FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
888 WNLE POWERED WHEELCHAIR
K Number: K142027
·
Decision Oct 7, 2014
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
3
Review Days
74
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Basic Information
- Device Name
- 888 WNLE POWERED WHEELCHAIR
- K Number
- K142027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pihsiang Machinery Mfg. Co., Ltd.
- Date Received
- July 25, 2014
- Decision Date
- October 7, 2014
- Product Code
- ITI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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