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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
Product CodeGZI
Regulation Number 882.5810
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONESS INC.
  SUBSTANTIALLY EQUIVALENT 5
BIONESS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CIONIC
  SUBSTANTIALLY EQUIVALENT 2
EVOLUTION DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HASOMED GMBH
  SUBSTANTIALLY EQUIVALENT 3
INNOVATIVE NEUROTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
MYNDTEC INC
  SUBSTANTIALLY EQUIVALENT 1
MYNDTEC INC.
  SUBSTANTIALLY EQUIVALENT 1
MYOLYN, LLC
  SUBSTANTIALLY EQUIVALENT 2
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ODSTOCK MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
OTTO BOCK HEALTHCARE PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
REHABTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTORATIVE THERAPIES INC.
  SUBSTANTIALLY EQUIVALENT 3
RESTORATIVE THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XFT MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
TECHLINK INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2017 2 2
2018 1 1
2019 4 4
2021 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4 4
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Operates Differently Than Expected 1 1
Electrical Overstress 1 1
Unintended Electrical Shock 1 1
Intermittent Energy Output 1 1
Electrical /Electronic Property Problem 1 1
High impedance 1 1
Mechanical Problem 1 1
Device Stops Intermittently 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
Partial thickness (Second Degree) Burn 4 4
Full thickness (Third Degree) Burn 4 4
Lead(s), Burn(s) From 2 2
Electric Shock 2 2
No Known Impact Or Consequence To Patient 2 2
Complaint, Ill-Defined 2 2
Burn(s) 2 2
Bone Fracture(s) 2 2
Muscle Spasm(s) 1 1
Emotional Changes 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Discomfort 1 1
No Code Available 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Innovative Neurotronics, Inc. II Jun-03-2009
2 Myolyn Inc. II Aug-16-2022
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