The following data is part of a premarket notification filed by Amigo Mobility Intl., Inc. with the FDA for Amigo J-9.
| Device ID | K940334 |
| 510k Number | K940334 |
| Device Name: | AMIGO J-9 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | AMIGO MOBILITY INTL., INC. 6693 DIXIE HWY. Bridgeport, MI 48722 |
| Contact | Andrea J Lupo |
| Correspondent | Andrea J Lupo AMIGO MOBILITY INTL., INC. 6693 DIXIE HWY. Bridgeport, MI 48722 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-05-18 |