FDA 510(k)

TaiChiA

K-Number: K193207 · 2020-08-07

Decision Date2020-08-07

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TaiChiA is the device name listed in this FDA 510(k) record. The listed applicant is Our United Corporation. It received FDA 510(k) clearance on 2020-08-07 under 510(k) 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. The listed applicant is Our United Corporation. The 510(k) number is K193207.

When did TaiChiA receive FDA 510(k) clearance?

TaiChiA received FDA 510(k) clearance on 2020-08-07, under 510(k) number K193207.

Who is the listed applicant for TaiChiA?

The FDA 510(k) record lists Our United Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TaiChiA?

The FDA product code for TaiChiA is IYE.

Other records listing Our United Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210921TaiChiB K203250TaiChiC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.