FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROUGHRIDER
K Number: K103212
·
Decision Jan 3, 2011
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
445
Applicant Total
1
Review Days
63
Basic Information
- Device Name
- ROUGHRIDER
- K Number
- K103212
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WHIRLWIND WHEELCHAIR INTERNATIONAL
- Date Received
- November 1, 2010
- Decision Date
- January 3, 2011
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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