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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wheelchair, standup
Regulation Description Standup wheelchair.
Product CodeIPL
Regulation Number 890.3900
Device Class 2


Premarket Reviews
ManufacturerDecision
COMFORT ORTHOPEDIC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
DAVISMADE, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE PRODUCTS UNLIMITED, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEVO AG
  SUBSTANTIALLY EQUIVALENT 3
LIFESTAND
  SUBSTANTIALLY EQUIVALENT 3
LLOYD LINDEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
R82 A/S
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

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