FDA 510(k)

TaiChiC

K-Number: K203250 · 2021-03-12

Decision Date2021-03-12

Product CodeIWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TaiChiC 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 2021-03-12 under 510(k) number K203250. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TaiChiC?

TaiChiC is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Our United Corporation. The 510(k) number is K203250.

When did TaiChiC receive FDA 510(k) clearance?

TaiChiC received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203250.

Who is the listed applicant for TaiChiC?

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 TaiChiC?

The FDA product code for TaiChiC is IWB.

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 K193207TaiChiA

Related Devices (Code: IWB)

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions AB K232854Leksell GammaPlan (LGP)Elekta Solutions AB K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions AB K203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, Inc.K190844Akesis GalaxyAkesis, Inc.

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.