The following data is part of a premarket notification filed by Wu's Tech Co., Ltd. with the FDA for Wu's Powered Wheelchair.
| Device ID | K181163 |
| 510k Number | K181163 |
| Device Name: | Wu's Powered Wheelchair |
| Classification | Wheelchair, Powered |
| Applicant | Wu's Tech Co., Ltd. No. 225, Yuan Peir St. Hsin-chu City, CN 30093 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min Wu's Tech Co., Ltd. No. 225, Yuan Peir St. Hsin-chu City, CN 30093 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2019-02-16 |
| Summary: | summary |