FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MECHANICAL WHEELCHAIR - L-FRAME SERIES
K Number: K071444
·
Decision Jul 27, 2007
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
445
Applicant Total
12
Review Days
64
Basic Information
- Device Name
- MECHANICAL WHEELCHAIR - L-FRAME SERIES
- K Number
- K071444
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- COLOURS 'N MOTION
- Date Received
- May 24, 2007
- Decision Date
- July 27, 2007
- 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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|---|---|---|---|
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| K984354 | MECHANICAL WHEELCHAIR | Jan 28, 1999 | Substantially Equivalent |
| K945151 | MECHANICAL WHEELCHAIR- G-FORCE | May 12, 1995 | Substantially Equivalent |
| K945153 | MECHANICAL WHEELCHAIR- LIL DIPPER | May 12, 1995 | Substantially Equivalent |
| K945150 | MECHANICAL WHEERCHAIR- ECLIPSE | May 12, 1995 | Substantially Equivalent |
| K945148 | MECHANICAL WHEELCHAIR- AVENGER | May 12, 1995 | Substantially Equivalent |
| K945149 | MECHANICAL WHEELCHAIR- CHALLENGER | May 12, 1995 | Substantially Equivalent |
| K945152 | MECHANICAL WHEELCHAIR- IMPACT | May 1, 1995 | Substantially Equivalent |
| K945534 | MECHANICAL WHEELCHAIR - BOING | Jan 2, 1995 | Substantially Equivalent |