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TPLC
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Device
stimulator, nerve, transcutaneous, for pain relief
Regulation Description
Transcutaneous electrical nerve stimulator for pain relief.
Product Code
GZJ
Regulation Number
882.5890
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOWAVE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
DELTA INTERNATIONAL SERVICES & LOGISTICS S.R.L
SUBSTANTIALLY EQUIVALENT
1
FAST TRACK TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
GIMER MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
GONGGUAN TUTAMEN METALWORK CO., LTD
SUBSTANTIALLY EQUIVALENT
1
ORIENTAL INSPIRATION LIMITED
SUBSTANTIALLY EQUIVALENT
1
PIERENKEMPER GMBH
SUBSTANTIALLY EQUIVALENT
1
SUBLIMED
SUBSTANTIALLY EQUIVALENT
1
TENSCARE LTD
SUBSTANTIALLY EQUIVALENT
1
TRUERELIEF
SUBSTANTIALLY EQUIVALENT
1
WAT MEDICAL TECHNOLOGY INC.
SUBSTANTIALLY EQUIVALENT
1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
SUBSTANTIALLY EQUIVALENT
2
ZYNEX MEDICAL OFFICER
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
10
10
2021
5
5
2022
4
4
2023
39
39
2024
12
12
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
23
23
Adverse Event Without Identified Device or Use Problem
9
9
Break
4
4
Improper or Incorrect Procedure or Method
3
3
Thermal Decomposition of Device
3
3
Use of Device Problem
3
3
Patient-Device Incompatibility
2
2
Output Problem
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Circuit Failure
1
1
Fire
1
1
Therapeutic or Diagnostic Output Failure
1
1
Battery Problem
1
1
Positioning Problem
1
1
Electromagnetic Interference
1
1
Smoking
1
1
Energy Output Problem
1
1
Mechanical Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Unintended Movement
1
1
Positioning Failure
1
1
Charging Problem
1
1
Failure to Power Up
1
1
Defective Component
1
1
Inadequate or Insufficient Training
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
15
15
Burn(s)
10
10
Pain
7
7
Erythema
7
7
Blister
6
6
Full thickness (Third Degree) Burn
5
5
Burn, Thermal
4
4
Discomfort
4
4
Electric Shock
3
3
Superficial (First Degree) Burn
3
3
No Consequences Or Impact To Patient
3
3
Partial thickness (Second Degree) Burn
3
3
Device Overstimulation of Tissue
2
2
Itching Sensation
2
2
Arrhythmia
2
2
Burning Sensation
2
2
Hypersensitivity/Allergic reaction
2
2
Bruise/Contusion
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Inadequate Pain Relief
2
2
Neuropathy
1
1
Fall
1
1
Undesired Nerve Stimulation
1
1
Tissue Damage
1
1
Failure of Implant
1
1
Hypoesthesia
1
1
Muscle Stimulation
1
1
Skin Inflammation
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Skin Burning Sensation
1
1
Reaction
1
1
Shock from Patient Lead(s)
1
1
Numbness
1
1
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