TaiChiC
K-Number: K203250 · 2021-03-12
ApplicantOur United Corporation
Decision Date2021-03-12
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TaiChiC is a medical device manufactured by Our United Corporation. It received FDA 510(k) clearance on 2021-03-12 under approval 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. It is manufactured by Our United Corporation. The 510(k) number is K203250.
When was TaiChiC approved by the FDA?
TaiChiC received FDA 510(k) clearance on 2021-03-12, under approval number K203250.
What company makes TaiChiC?
TaiChiC is manufactured by Our United Corporation.
What is the FDA product code for TaiChiC?
The FDA product code for TaiChiC is IWB.
Other Devices by Our United Corporation
Related Devices (Code: IWB)
K160440Leksell Gamma Knife IconElekta Instrument AB
K172706GammaPod - Model AXcision Medical Systems, LLC
K180571GammaPodXcision Medical Systems, LLC
K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB
K173791Leksell GammaPlanElekta Instrument AB
K190844Akesis GalaxyAkesis, Inc.
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.