The following data is part of a premarket notification filed by Zhejiang Innuovo Rehabilitation Devices Co.,ltd with the FDA for Mobility Scooter.
| Device ID | K220206 |
| 510k Number | K220206 |
| Device Name: | Mobility Scooter |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone Dongyang, CN |
| Contact | Leo Zheng |
| Correspondent | Jarvis Wu Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue 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 | 2022-01-25 |
| Decision Date | 2022-03-24 |