FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAMBLER
K Number: K011401
·
Decision Jul 13, 2001
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
327
Applicant Total
1
Review Days
67
Basic Information
- Device Name
- RAMBLER
- K Number
- K011401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RAMBLER MOBILITY, INC.
- Date Received
- May 7, 2001
- Decision Date
- July 13, 2001
- 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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