FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
K Number: K091113
·
Decision May 11, 2009
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
20
Review Days
24
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Basic Information
- Device Name
- MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
- K Number
- K091113
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pride Mobility Products Corp.
- Date Received
- April 17, 2009
- Decision Date
- May 11, 2009
- 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 |
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