FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
K Number: K871391
·
Decision May 6, 1987
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
4
Applicant Total
7
Review Days
29
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Basic Information
- Device Name
- AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
- K Number
- K871391
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3940
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Amigo Sales, Inc.
- Date Received
- April 7, 1987
- Decision Date
- May 6, 1987
- Product Code
- INF
- 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 |
|---|---|---|---|
| INF | Scale, Platform, Wheelchair | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INF), ordered by most recent decision date.
U.S. MEDICAL PS-6000 WHEELCHAIR SCALE
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ULTRAFLOTATION MEDICAL WHEELCHAIR
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WHEEL'N WEIGH
FDA 510(k)
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Other Clearances by Amigo Sales, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853918 | THE SPORTSTER (ELECTRIFIED WHEELCHAIR) | Jan 13, 1986 | Substantially Equivalent |
| K852557 | ALL TERRAIN AMIGO | Aug 22, 1985 | Substantially Equivalent |
| K830345 | SCOOTER, VEHICLE MOTORIZED | Mar 10, 1983 | Substantially Equivalent |
| K823117 | HITCH HIKER | Nov 16, 1982 | Substantially Equivalent |
| K820858 | ESCORT | Apr 8, 1982 | Substantially Equivalent |
| K800209 | BOOTS - OUTDOOR CARRIER FOR THE AMIGO | Feb 22, 1980 | Substantially Equivalent |