The following data is part of a premarket notification filed by Advanced Vehicle Concepts Ltd. with the FDA for Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350.
| Device ID | K170634 |
| 510k Number | K170634 |
| Device Name: | Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | Advanced Vehicle Concepts Ltd. 7 Stadium Way Cradock Road Luton, GB Lu4 0jf |
| Contact | Mark Nicholls |
| Correspondent | Rajal A. Vaibhav mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-02 |
| Decision Date | 2017-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B837S5510 | K170634 | 000 |
| 05060756880009 | K170634 | 000 |