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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
Definition TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Product CodeNUH
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGSHA YUWEN MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
CHANGSHA YUWEN MEDICAL EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING ROB LINKA SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN BOHUIKANG TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
EASYMED INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
FAMIDOC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEMORE TECHNOLOGY CO LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HUA KAI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU XINBO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYMMAX TECHNOLOGY SHENZEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HI-DOW INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HINGE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HIVOX BIOTEK INC.
  SUBSTANTIALLY EQUIVALENT 6
HONG KONG ETECH GROUPS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 4
JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 3
LIFECARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC
  SUBSTANTIALLY EQUIVALENT 1
MARCHAN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MINGHUANGDA ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MEDKINETIC MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NU-BECA & MAXCELLENT CO.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORIENTAL INSPIRATION LIMITED
  SUBSTANTIALLY EQUIVALENT 2
POURANG BRAL, DDS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SELF DOCTOR CARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AS TEC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGJILIAN ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN FUTURE ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIANFENG ELECTRONIC TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIANFENG ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN LEADING PERFECTION TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEQING MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN OSTO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YIRAN INTELLIGENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUEHUA XINSEN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TENSCARE LTD
  SUBSTANTIALLY EQUIVALENT 2
TENSCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIMEWAVER PRODUCTION GMBH
  SUBSTANTIALLY EQUIVALENT 1
TOP-RANK HEALTH CARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TYECE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZMI ELECRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 8 8
2021 7 7
2022 2 2
2023 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Excessive Heating 5 5
Therapeutic or Diagnostic Output Failure 4 4
Insufficient Information 4 4
Patient-Device Incompatibility 3 3
Temperature Problem 2 2
Fire 2 2
High impedance 2 2
Shipping Damage or Problem 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Appropriate Term/Code Not Available 1 1
Unintended Electrical Shock 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 5 5
Skin Irritation 4 4
No Known Impact Or Consequence To Patient 4 4
Itching Sensation 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Burn, Thermal 3 3
Partial thickness (Second Degree) Burn 3 3
Erythema 3 3
Burn(s) 2 2
Superficial (First Degree) Burn 2 2
Patient Problem/Medical Problem 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Acoustic Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Therapeutic Effects, Unexpected 1 1
Skin Discoloration 1 1

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