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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brain injury adjunctive interpretive oculomotor assessment aid
Definition A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
Product CodeQEA
Regulation Number 882.1455
Device Class 2


Premarket Reviews
ManufacturerDecision
OCULOGICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNCTHINK, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 OCULOGICA II Aug-28-2019
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