FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
K Number: K242448
·
Decision Jan 2, 2025
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
9
Review Days
139
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Basic Information
- Device Name
- Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
- K Number
- K242448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anhui Jbh Medical Apparatus Co., Ltd.
- Date Received
- August 16, 2024
- Decision Date
- January 2, 2025
- 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 |
Similar 510(k) Clearances
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Other Clearances by Anhui Jbh Medical Apparatus Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251606 | Power Wheelchair (D26) | Jun 25, 2025 | Substantially Equivalent |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Feb 28, 2025 | Substantially Equivalent |
| K242468 | Power Wheelchair (D10, D12, D15, D17, D20, D37) | Dec 31, 2024 | Substantially Equivalent |
| K242252 | Power Wheelchair | Dec 27, 2024 | Substantially Equivalent |
| K241854 | Power Wheelchair | Oct 4, 2024 | Substantially Equivalent |
| K212092 | Portable Folding Electric Wheelchair (Model: DC01) | May 6, 2022 | Substantially Equivalent |
| K212090 | Electric Scooter | Apr 22, 2022 | Substantially Equivalent |
| K210302 | Disposable Medical mask | May 14, 2021 | Substantially Equivalent |