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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
21 EQUIPMENT S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
A-1 ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
AURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AVAZZIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BELEGA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODY TRIM INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CAROL COLE COMPANY DBA NUFACE
  SUBSTANTIALLY EQUIVALENT 2
CAROL COLE COMPANY DBA NUFACE®
  SUBSTANTIALLY EQUIVALENT 1
CAROLE COLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
EMA AESTHETICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOREO, INC.
  SUBSTANTIALLY EQUIVALENT 1
GESKE BEAUTY TECH GMBH
  SUBSTANTIALLY EQUIVALENT 1
JOHARI DIGITAL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICRO CURRENT TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
NSE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIER NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAJA TRADING COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENB CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOZEMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DACHI COMMUNICATION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DJ MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIANCHAO INTELLIGENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NUON MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN QIANYU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ULIKE SMART ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THERAGUN, INC.
  SUBSTANTIALLY EQUIVALENT 1
XTREEM PULSE
  SUBSTANTIALLY EQUIVALENT 1
XTREEM PULSE, LLC
  SUBSTANTIALLY EQUIVALENT 2
YA-MAN, LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZIIP, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 6 6
2022 5 6
2023 1 1
2024 4 4
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 4 5
Adverse Event Without Identified Device or Use Problem 4 4
Patient Device Interaction Problem 3 3
Device Markings/Labelling Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
Off-Label Use 1 1
Output Problem 1 1
Material Discolored 1 1
Labelling, Instructions for Use or Training Problem 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arrhythmia 5 5
Pain 5 6
Skin Inflammation/ Irritation 3 4
Inflammation 3 3
Nerve Damage 3 3
Sleep Dysfunction 2 2
Nausea 2 2
Dizziness 2 2
Rash 2 2
Undesired Nerve Stimulation 2 2
Burning Sensation 2 2
Unspecified Tissue Injury 2 2
Laceration(s) 2 2
Low Blood Pressure/ Hypotension 1 1
Swollen Lymph Nodes/Glands 1 1
Neuralgia 1 1
Headache 1 1
Hormonal Imbalance 1 1
Deformity/ Disfigurement 1 1
Loss of consciousness 1 1
Hemorrhage/Bleeding 1 1
Eye Pain 1 1
Sore Throat 1 1
Physical Asymmetry 1 1
Convulsion/Seizure 1 1
Tachycardia 1 1
Bradycardia 1 1
Scar Tissue 1 1
Dyspnea 1 1
Erythema 1 1
Discomfort 1 1
Retinal Detachment 1 1
Neck Pain 1 1
Device Overstimulation of Tissue 1 1
Skin Discoloration 1 1
Myalgia 1 1
Skin Disorders 1 1
Chemical Exposure 1 2
Atrial Fibrillation 1 1
Itching Sensation 1 1
Local Reaction 1 1
Malaise 1 1
Presyncope 1 1
Hypersensitivity/Allergic reaction 1 1
Syncope/Fainting 1 1

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