The following data is part of a premarket notification filed by Amigo Mobility Intl., Inc. with the FDA for Amigo Model 680000 (amigo Excite F 350).
Device ID | K992619 |
510k Number | K992619 |
Device Name: | AMIGO MODEL 680000 (AMIGO EXCITE F 350) |
Classification | Wheelchair, Powered |
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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-04 |
Decision Date | 1999-10-25 |