The following data is part of a premarket notification filed by Agile Distributors Llc with the FDA for Quingo Flyte Mobility Scooter.
Device ID | K171256 |
510k Number | K171256 |
Device Name: | Quingo Flyte Mobility Scooter |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | Agile Distributors LLC 2283 East Zion Way Chandler, AZ 85249 |
Contact | Steven Mahaffy |
Correspondent | Steven Mahaffy Agile Distributors LLC 2283 East Zion Way Chandler, AZ 85249 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-28 |
Decision Date | 2017-06-08 |
Summary: | summary |