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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 1
CIONIC
  SUBSTANTIALLY EQUIVALENT 2
CIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MYNDTEC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MYOLYN, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUVOTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XFT MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SYNAPSE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Myolyn Inc. II Aug-16-2022
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