TaiChiB

FDA 510(k) K210921 · Our United Corporation

Substantially Equivalent

510(k) numberK210921

Submission

Device name
TaiChiB
Applicant
Our United Corporation
Xi'An, CN
Received
March 29, 2021
Decision date
November 2, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was TaiChiB cleared by the FDA?

TaiChiB (K210921) received a 510(k) decision of Substantially Equivalent on November 2, 2021, 218 days after the submission was received.

What is the product code of K210921?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.