The following data is part of a premarket notification filed by Our United Corporation with the FDA for Taichia.
| Device ID | K193207 |
| 510k Number | K193207 |
| Device Name: | TaiChiA |
| Classification | Accelerator, Linear, Medical |
| Applicant | Our United Corporation 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, NO.66 Xi'an, CN 710018 |
| Contact | Qi Liu |
| Correspondent | Qi Liu Our United Corporation 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, NO.66 Xi'an, CN 710018 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-20 |
| Decision Date | 2020-08-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TAICHIA 79325993 not registered Live/Pending |
OUR UNITED CORPORATION 2021-06-30 |