AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
FDA 510(k) clearance K871391 · decided 1987-05-06
Clearance details
- K-number
- K871391
- Device name
- AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
- Applicant
- Amigo Sales, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-07
- Decision date
- 1987-05-06
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- INF
- Device class
- 1
- Regulation number
- 890.3940
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Bridgeport, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (K924441) | U.S. Medical Corp. | 1993-02-12 |
| ACME MODEL 8500 WHEELCHAIR SCALE (K910055) | Acme Medical Scale Co. | 1991-01-14 |
| ULTRAFLOTATION MEDICAL WHEELCHAIR (K884908) | Medical Flotation Systems, Inc. | 1988-12-27 |
| WHEEL'N WEIGH (K760327) | Acme Medical Scale Co. | 1976-10-20 |
Recalls involving this device
No recalls on record reference this clearance.