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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shoe with adjustable sole units
Definition Intended to adjust the foot’s points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb
Product CodeQDT
Regulation Number 890.3475
Device Class 1


Premarket Reviews
ManufacturerDecision
APOS MEDICAL ASSETS LTD.
  SUBSTANTIALLY EQUIVALENT 1

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