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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, transcutaneous electrical, aesthetic purposes
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Product CodeNFO
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
AVAZZIA, INC
  SUBSTANTIALLY EQUIVALENT 1
CAROL COLE COMPANY DBA NUFACE
  SUBSTANTIALLY EQUIVALENT 6
CAROLE COLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
FOREO, INC.
  SUBSTANTIALLY EQUIVALENT 1
HABALAN MED & BEAUTY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK
  SUBSTANTIALLY EQUIVALENT 1
INFINITUS (CHINA) COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MICRO CURRENT TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUTRA LUXE MD, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DJ MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAMA RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERAGUN, INC.
  SUBSTANTIALLY EQUIVALENT 1
TROPHY SKIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
VUPIESSE S.R.L
  SUBSTANTIALLY EQUIVALENT 1
XTREEM PULSE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIIP, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIIP,LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 5 5
2019 1 1
2020 6 6
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Overheating of Device 1 1
Off-Label Use 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dizziness 4 4
Inflammation 3 3
Arrhythmia 3 3
Headache 3 3
Pain 3 3
Swelling 3 3
Rash 2 2
Hemorrhage/Bleeding 2 2
Dysphagia/ Odynophagia 2 2
Increased Sensitivity 2 2
Nerve Damage 1 1
Malaise 1 1
Sensitivity of Teeth 1 1
Tooth Fracture 1 1
Neck Pain 1 1
Skin Inflammation 1 1
Sleep Dysfunction 1 1
No Known Impact Or Consequence To Patient 1 1
Convulsion/Seizure 1 1
Presyncope 1 1
Neuralgia 1 1
Unspecified Tissue Injury 1 1
Dyspnea 1 1
Fatigue 1 1
Hair Loss 1 1
Chest Pain 1 1
Dry Eye(s) 1 1
Local Reaction 1 1
Retinal Detachment 1 1
Blurred Vision 1 1
Hot Flashes/Flushes 1 1
Twitching 1 1

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