The following data is part of a premarket notification filed by Zhejiang Innuovo Rehabilitation Devices Co., Ltd. with the FDA for Power Wheelchair (n5515b).
| Device ID | K220747 |
| 510k Number | K220747 |
| Device Name: | Power Wheelchair (N5515B) |
| Classification | Wheelchair, Powered |
| Applicant | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. No.196 Industry Road, Hengdian Movie Zone Dongyang, CN |
| Contact | Leo Zheng |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-05-12 |