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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital therapy device for convergence insufficiency
Regulation Description Fixation device.
Definition A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
Product CodeSBN
Regulation Number 886.1290
Device Class 1


Premarket Reviews
ManufacturerDecision
OCULOMOTOR TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1

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