The following data is part of a premarket notification filed by Amigo Mobility Intl., Inc. with the FDA for Amigo Rt.
| Device ID | K981121 |
| 510k Number | K981121 |
| Device Name: | AMIGO RT |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-27 |
| Decision Date | 1998-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863048000315 | K981121 | 000 |