The following data is part of a premarket notification filed by Our United Corporation with the FDA for Taichic.
Device ID | K203250 |
510k Number | K203250 |
Device Name: | TaiChiC |
Classification | System, Radiation Therapy, Radionuclide |
Applicant | Our United Corporation Room 10301, 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 Room 10301, 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, No.66 Xi'an, CN 710018 |
Product Code | IWB |
CFR Regulation Number | 892.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-04 |
Decision Date | 2021-03-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TAICHIC 79325990 not registered Live/Pending |
OUR UNITED CORPORATION 2021-06-30 |