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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, measuring
Regulation Description Measuring exercise equipment.
Product CodeISD
Regulation Number 890.5360
Device Class 2


Premarket Reviews
ManufacturerDecision
BALTIMORE THERAPEUTIC EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
BATTLE CREEK MANUFACTURERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CYBEX
  SUBSTANTIALLY EQUIVALENT 1
ERGOLINE GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 2

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