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510(k) K210921

TaiChiB by Our United Corporation — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2021
Date Received
March 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Our United Corporation

  • K203250 — TaiChiC (March 12, 2021)
  • K193207 — TaiChiA (August 7, 2020)

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