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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, nerve, transcutaneous, over-the-counter
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Product CodeNUH
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
AVAZZIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BAYER PHARMA, AG
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL LIFE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EASYWELL BIOMEDICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
FUJI DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
HOLLYWOG LLC
  SUBSTANTIALLY EQUIVALENT 1
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
IQ TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFECARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDIANATECHNOLOGIES CORP
  SUBSTANTIALLY EQUIVALENT 5
NEUROMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEWMARK, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 5
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
PFIZER INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN EAPPLY TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SMARTMEDICALDEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THIMBLE BIOELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYECE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 13 13
2017 21 21
2018 18 18
2019 5 5
2020 8 8
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23 23
Insufficient Information 16 16
Patient-Device Incompatibility 5 5
Device Operates Differently Than Expected 4 4
Therapeutic or Diagnostic Output Failure 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Output Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Overheating of Device 2 2
Failure to Power Up 1 1
Off-Label Use 1 1
Shipping Damage or Problem 1 1
Loss of or Failure to Bond 1 1
Thermal Decomposition of Device 1 1
Failure to Conduct 1 1
Fail-Safe Design Failure 1 1
Gel Leak 1 1
Labelling, Instructions for Use or Training Problem 1 1
Output above Specifications 1 1
Defective Component 1 1
Invalid Sensing 1 1
Defective Device 1 1
Smoking 1 1
Unexpected Therapeutic Results 1 1
Use of Device Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Failure to Shut Off 1 1
Material Integrity Problem 1 1
Torn Material 1 1
Appropriate Term/Code Not Available 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 11 11
Pain 9 9
Burn, Thermal 8 8
Electric Shock 5 5
No Known Impact Or Consequence To Patient 5 5
Erythema 5 5
Skin Irritation 5 5
Local Reaction 4 4
Itching Sensation 4 4
Undesired Nerve Stimulation 3 3
Atrial Fibrillation 3 3
Skin Discoloration 3 3
Tissue Damage 3 3
Burning Sensation 3 3
Tingling 2 2
No Code Available 2 2
Rash 2 2
Therapeutic Effects, Unexpected 2 2
Thrombosis 2 2
No Consequences Or Impact To Patient 2 2
Hypersensitivity/Allergic reaction 2 2
Bruise/Contusion 2 2
Nerve Damage 2 2
Scar Tissue 1 1
Paralysis 1 1
Peeling 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Atrial Flutter 1 1
Cardiac Arrest 1 1
Heart Failure 1 1
Discomfort 1 1
Arthralgia 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Loss of consciousness 1 1
Skin Inflammation 1 1
Sweating 1 1
Palpitations 1 1
Transient Ischemic Attack 1 1
Skin Erosion 1 1
Swelling 1 1
Tachycardia 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Partial thickness (Second Degree) Burn 1 1
Shock from Patient Lead(s) 1 1
No Information 1 1
Dizziness 1 1
Seizures, Grand-Mal 1 1
Patient Problem/Medical Problem 1 1
Caustic/Chemical Burns 1 1

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