FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Power wheelchair (Model:BC-EA8000)
K Number: K232121
·
Decision Sep 15, 2023
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
3
Review Days
60
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Basic Information
- Device Name
- Power wheelchair (Model:BC-EA8000)
- K Number
- K232121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ningbo Baichen Medical Devices Co., Ltd.
- Date Received
- July 17, 2023
- Decision Date
- September 15, 2023
- 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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