FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Powered Mobility Scooter
K Number: K250027
·
Decision Feb 21, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
4
Review Days
46
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 Mobility Scooter
- K Number
- K250027
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intradin (Shanghai) Machinery Co., Ltd.
- Date Received
- January 6, 2025
- Decision Date
- February 21, 2025
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INI), ordered by most recent decision date.
Virgo Mobility Scooter (Virgo-D,Virgo-F)
FDA 510(k)
FDA Class 2
·Physical Medicine
Scooter (YD-03)
FDA 510(k)
FDA Class 2
·Physical Medicine
Mobility Scooter (Air Carbon)
FDA 510(k)
FDA Class 2
·Physical Medicine
Mobility Scooter (X-12, X-14, X-17)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electrical Scooter (SM4226)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Mobility Scooter (MJMA01, MJMA02)
FDA 510(k)
FDA Class 2
·Physical Medicine