The following data is part of a premarket notification filed by Amigo Sales, Inc. with the FDA for The Sportster (electrified Wheelchair).
| Device ID | K853918 |
| 510k Number | K853918 |
| Device Name: | THE SPORTSTER (ELECTRIFIED WHEELCHAIR) |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | AMIGO SALES, INC. 6693 DIXIE HIGHWAY Bridgeport, MI 48722 |
| Contact | Warren C Light |
| Correspondent | Warren C Light AMIGO SALES, INC. 6693 DIXIE HIGHWAY Bridgeport, MI 48722 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-23 |
| Decision Date | 1986-01-13 |