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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interactive rehabilitation exercise devices
Product CodeLXJ
Regulation Number 890.5360
Device Class 2


Premarket Reviews
ManufacturerDecision
BARRON ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINDMAZE SA
  SUBSTANTIALLY EQUIVALENT 2
QUALISYS AB
  SUBSTANTIALLY EQUIVALENT 1
REFLEXION HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIFIC ANALYTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UINCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Seizures, Grand-Mal 1 1

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