The following data is part of a premarket notification filed by Amigo Mobility Intl., Inc. with the FDA for Amigo Escort 7.5, Model 760001 Phs.
| Device ID | K092936 |
| 510k Number | K092936 |
| Device Name: | AMIGO ESCORT 7.5, MODEL 760001 PHS |
| Classification | Wheelchair, Powered |
| Applicant | AMIGO MOBILITY INTL., INC. 6693 DIXIE HWY. Bridgeport, MI 48722 |
| Contact | Mike Labrake |
| Correspondent | Mike Labrake 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 | 2009-09-24 |
| Decision Date | 2009-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863048000346 | K092936 | 000 |