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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
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
SYNAPSE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3
2023 1 1
2024 1 1
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Patient Device Interaction Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Problem 1 1
Unintended Electrical Shock 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Electric Shock 2 2
Burn(s) 2 2
Erythema 2 2
Superficial (First Degree) Burn 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Inflammation/ Irritation 1 1
Bone Fracture(s) 1 1
Blister 1 1
Fall 1 1
Limb Fracture 1 1
Partial thickness (Second Degree) Burn 1 1

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