The following data is part of a premarket notification filed by Amigo Mobility Intl., Inc. with the FDA for Amigo Model 590000.
Device ID | K983987 |
510k Number | K983987 |
Device Name: | AMIGO MODEL 590000 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | AMIGO MOBILITY INTL., INC. 6693 DIXIE HWY. Bridgeport, MI 48722 |
Contact | Dale Confer |
Correspondent | Dale Confer 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 | 1998-11-09 |
Decision Date | 1999-06-08 |