FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
MERITS MODEL P322FWD POWERED WHEELCHAIR
K Number: K122357
·
Decision Jan 9, 2013
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
550
Applicant Total
18
Review Days
159
Basic Information
- Device Name
- MERITS MODEL P322FWD POWERED WHEELCHAIR
- K Number
- K122357
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MERITS HEALTH PRODUCTS CO., LTD.
- Date Received
- August 3, 2012
- Decision Date
- January 9, 2013
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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