Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
ACUMED MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
AEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI JINJIANQIAO MED-TECH CO,. LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVAZZIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER HEALTHCARE LLC
  SUBSTANTIALLY EQUIVALENT 1
BAYER HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEWELL CONNECT CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL LIFE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHANGSHA YUWEN MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
CHANGSHA YUWEN MEDICAL EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHATTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING ROB LINKA SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD
  SUBSTANTIALLY EQUIVALENT 3
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN BOHUIKANG TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
EASYMED INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EASYMED INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EASYWELL BIOMEDICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDURANCE THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LDT.
  SUBSTANTIALLY EQUIVALENT 2
EVERYWAY MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
FAMIDOC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJI DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
GEMORE 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 2
GURIN PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GYMMAX TECHNOLOGY SHENZEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTHCARE INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HEALTHMATE INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK LLC
  SUBSTANTIALLY EQUIVALENT 1
HI-DOW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HI-DOW INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HINGE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HIVOX BIOTEK INC.
  SUBSTANTIALLY EQUIVALENT 7
HIVOX BIOTEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOLLYWOG LLC
  SUBSTANTIALLY EQUIVALENT 1
HOLLYWOG, LLC
  SUBSTANTIALLY EQUIVALENT 1
HONG KONG ETECH GROUPS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 4
INTERNATIONAL TRADE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
IQ TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 2
JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 3
LASER HEALTH TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFECARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
M.I.TECH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC
  SUBSTANTIALLY EQUIVALENT 1
MARC PRO
  SUBSTANTIALLY EQUIVALENT 1
MARCHAN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDECELL US, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDIRUNE CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
MID-AMERICA MEDICAL INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
MINGHUANGDA ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NEUROMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEWMARK, INC.
  SUBSTANTIALLY EQUIVALENT 3
NINGBO MEDKINETIC MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NU-BECA & MAXCELLENT CO.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 7
ORIENTAL INSPIRATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PDI WORKS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
PFIZER INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS CONSUMER LIFESTYLE
  SUBSTANTIALLY EQUIVALENT 1
PINOOK USA
  SUBSTANTIALLY EQUIVALENT 1
PLAYMAKAR INC.
  SUBSTANTIALLY EQUIVALENT 1
POURANG BRAL, DDS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRIZM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROSPERA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SAVIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SELF DOCTOR CARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AS TEC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AS-TEC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DONGJILIAN ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN EAPPLY TECHNOLOGY 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 JINGKEHUI ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
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 5
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YIRAN INTELLIGENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUEHUA XINSEN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMARTMEDICALDEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUNMAS (H.K.) TRADING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TENSCARE LTD
  SUBSTANTIALLY EQUIVALENT 2
TENSCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
THIMBLE BIOELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIMEWAVER PRODUCTION GMBH
  SUBSTANTIALLY EQUIVALENT 1
TOHKAI PRECISION ELECTRICAL MANUFACTORY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TOP-RANK HEALTH CARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIOWAVE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TYECE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TYECE LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 8
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZMI ELECRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 11 11
2016 13 13
2017 21 21
2018 18 18
2019 5 5
2020 8 8
2021 7 7
2022 2 2
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32 32
Insufficient Information 22 22
Device Operates Differently Than Expected 5 5
Patient-Device Incompatibility 5 5
Improper or Incorrect Procedure or Method 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Therapeutic or Diagnostic Output Failure 4 4
Overheating of Device 4 4
Excessive Heating 4 4
Output Problem 3 3
Temperature Problem 2 2
Thermal Decomposition of Device 2 2
Appropriate Term/Code Not Available 2 2
High impedance 2 2
Fire 2 2
Unintended Electrical Shock 2 2
Unexpected Therapeutic Results 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Output above Specifications 1 1
Invalid Sensing 1 1
Loss of or Failure to Bond 1 1
Shipping Damage or Problem 1 1
Use of Device Problem 1 1
Smoking 1 1
Failure to Conduct 1 1
Positioning Problem 1 1
Defective Device 1 1
Torn Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Gel Leak 1 1
Failure to Shut Off 1 1
Fail-Safe Design Failure 1 1
Unexpected Shutdown 1 1
Failure to Power Up 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 16 16
Pain 12 12
Burn, Thermal 9 9
Partial thickness (Second Degree) Burn 9 9
Electric Shock 6 6
No Known Impact Or Consequence To Patient 5 5
Skin Irritation 5 5
Erythema 5 5
Itching Sensation 5 5
Tissue Damage 4 4
Local Reaction 4 4
Shock 3 3
Skin Discoloration 3 3
Burning Sensation 3 3
Nerve Damage 3 3
Undesired Nerve Stimulation 3 3
Atrial Fibrillation 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Code Available 3 3
Superficial (First Degree) Burn 2 2
Neck Pain 2 2
No Consequences Or Impact To Patient 2 2
Tingling 2 2
Numbness 2 2
Bruise/Contusion 2 2
Chest Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Swelling 2 2
Therapeutic Effects, Unexpected 2 2
Thrombosis 2 2
Paralysis 2 2
Peeling 2 2
Rash 2 2
Skin Erosion 1 1
Scar Tissue 1 1
Scarring 1 1
Tachycardia 1 1
Seizures, Grand-Mal 1 1
Transient Ischemic Attack 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Muscle Spasm(s) 1 1
Cardiac Arrest 1 1
Atrial Flutter 1 1
Abrasion 1 1
Acoustic Shock 1 1
Loss of consciousness 1 1
Twitching 1 1
Dizziness 1 1
Heart Failure 1 1
Discomfort 1 1
Injury 1 1
Arthralgia 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Reaction, Injection Site 1 1
Skin Inflammation 1 1
Sweating 1 1
Palpitations 1 1
Blood Loss 1 1
Caustic/Chemical Burns 1 1
Patient Problem/Medical Problem 1 1
Shock from Patient Lead(s) 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1

-
-