The following data is part of a premarket notification filed by Yongkang Dingchang Industry & Trade Co., Ltd. with the FDA for Scooter, Model: R-100.
| Device ID | K182411 |
| 510k Number | K182411 |
| Device Name: | Scooter, Model: R-100 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | Yongkang Dingchang Industry & Trade Co., LTD. No99, HuaxiRoad, Xicheng Street Yongkang, CN 321300 |
| Contact | Cheng Chen |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, CN 102401 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975991680019 | K182411 | 000 |
| 06976477180030 | K182411 | 000 |
| 06976477180023 | K182411 | 000 |
| 06976477180016 | K182411 | 000 |