TaiChiA
K-Number: K193207 · 2020-08-07
ApplicantOur United Corporation
Decision Date2020-08-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TaiChiA is a medical device manufactured by Our United Corporation. It received FDA 510(k) clearance on 2020-08-07 under approval number K193207. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TaiChiA?
TaiChiA is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by Our United Corporation. The 510(k) number is K193207.
When was TaiChiA approved by the FDA?
TaiChiA received FDA 510(k) clearance on 2020-08-07, under approval number K193207.
What company makes TaiChiA?
TaiChiA is manufactured by Our United Corporation.
What is the FDA product code for TaiChiA?
The FDA product code for TaiChiA is IYE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.