FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Powered Wheelchair (NXN20-208, NXN20-211)
K Number: K241603
·
Decision Nov 20, 2024
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
4
Review Days
169
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Powered Wheelchair (NXN20-208, NXN20-211)
- K Number
- K241603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhejiang Nysin Medical Co., Ltd.
- Date Received
- June 4, 2024
- Decision Date
- November 20, 2024
- 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
Other 510(k) clearances with the same product code (ITI), ordered by most recent decision date.
Power Wheelchair (W5915B, W5915C, W5915D)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (S500-6)
FDA 510(k)
FDA Class 2
·Physical Medicine
WHILL (WHILL Model C2)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Wheelchair (N5515A, N5516, N5517A, N5519)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (DF506)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (Y207BL)
FDA 510(k)
FDA Class 2
·Physical Medicine