The following data is part of a premarket notification filed by Amigo Sales, Inc. with the FDA for Scooter, Vehicle Motorized.
| Device ID | K830345 |
| 510k Number | K830345 |
| Device Name: | SCOOTER, VEHICLE MOTORIZED |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | AMIGO SALES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-28 |
| Decision Date | 1983-03-10 |