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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device goniometer, ac-powered
Regulation Description Goniometer.
Product CodeKQX
Regulation Number 888.1500
Device Class 1


Premarket Reviews
ManufacturerDecision
BALTIMORE THERAPEUTIC EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CYBEX
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
FASSTECH
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

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