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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, neuromuscular, external functional
Regulation Description External functional neuromuscular stimulator.
Product CodeGZI
Regulation Number 882.5810
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONESS INC.
  SUBSTANTIALLY EQUIVALENT 3
BIONESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HASOMED GMBH
  SUBSTANTIALLY EQUIVALENT 2
INNOVATIVE NEUROTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MYNDTEC INC
  SUBSTANTIALLY EQUIVALENT 1
MYOLYN, LLC
  SUBSTANTIALLY EQUIVALENT 1
ODSTOCK MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE, GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XFT MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TECHLINK INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High impedance 1
Electrical Overstress 1
Electrical /Electronic Property Problem 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 4


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