The following data is part of a premarket notification filed by Nanjing Jin Bai He Medical Apparatus Co., Ltd with the FDA for Scooter (model: Fdb01).
| Device ID | K201196 |
| 510k Number | K201196 |
| Device Name: | Scooter (Model: FDB01) |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | Nanjing Jin Bai He Medical Apparatus Co., Ltd No. 12, Wuge Rd, Jiangning Nanjing, CN 210000 |
| Contact | Dandan Yang |
| Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, CN 200122 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-04 |
| Decision Date | 2021-06-25 |