FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACTIVE LIGHTWEIGHT WHEELCHAIR
K Number: K864684
·
Decision Dec 16, 1986
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
14
Review Days
14
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Basic Information
- Device Name
- ACTIVE LIGHTWEIGHT WHEELCHAIR
- K Number
- K864684
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- A-Bec Mobility, Inc.
- Date Received
- December 2, 1986
- Decision Date
- December 16, 1986
- 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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ICON 35; ICON 45; ICON 60; ICON 30FAF
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FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by A-Bec Mobility, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880425 | STERLING (MOTORIZED VEHICLE) | Feb 16, 1988 | Substantially Equivalent |
| K880423 | TARGA (WHEELCHAIR) | Feb 16, 1988 | Substantially Equivalent |
| K880424 | SCOOTA BUG (MOTORIZED VEHICLE) | Feb 16, 1988 | Substantially Equivalent |
| K865005 | A-BEC 41 | Feb 6, 1987 | Substantially Equivalent |
| K865009 | A-BEC 47 | Feb 6, 1987 | Substantially Equivalent |
| K865004 | A-BEC 40 POWER WHEELCHAIR | Feb 6, 1987 | Substantially Equivalent |
| K865003 | A-BEC 46 | Feb 6, 1987 | Substantially Equivalent |
| K865008 | A-BEC 17 | Feb 6, 1987 | Substantially Equivalent |
| K865002 | A-BEC 18 | Feb 6, 1987 | Substantially Equivalent |
| K865001 | A-BEC FIREBALL 40 | Feb 6, 1987 | Substantially Equivalent |