The following data is part of a premarket notification filed by Amigo Sales, Inc. with the FDA for Amigo-a288310 (scooter, Commuter Cart, 3-wheeled).
| Device ID | K871391 |
| 510k Number | K871391 |
| Device Name: | AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) |
| Classification | Scale, Platform, Wheelchair |
| Applicant | AMIGO SALES, INC. 6693 DIXIE HIGHWAY Bridgeport, MI 48722 |
| Contact | Robert K Shrode |
| Correspondent | Robert K Shrode AMIGO SALES, INC. 6693 DIXIE HIGHWAY Bridgeport, MI 48722 |
| Product Code | INF |
| CFR Regulation Number | 890.3940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-07 |
| Decision Date | 1987-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863048000322 | K871391 | 000 |
| 00863048000308 | K871391 | 000 |