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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
Product CodeNFO
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
21 EQUIPMENT S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
AVAZZIA, INC
  SUBSTANTIALLY EQUIVALENT 1
BELEGA INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-MEDICAL RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSONIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BODY TRIM INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
CAROL COLE COMPANY
  SUBSTANTIALLY EQUIVALENT 3
CAROL COLE COMPANY DBA NUFACE
  SUBSTANTIALLY EQUIVALENT 6
CAROLE COLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DAKA INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  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
JOHARI DIGITAL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
JOHARI DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LETO ENTERPRISE LTD.
  SUBSTANTIALLY EQUIVALENT 1
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MICRO CURRENT TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K181062  Ultra Facial Toning System
  2.  K183189  Ultra OTC Facial Toning System
  3.  K233095  S21 OTC Transcutaneous Electrical Nerve Stimulator
  4.  K233525  MF SC Facial Toning System
NSE PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
NUSKIN
  SUBSTANTIALLY EQUIVALENT 1
NUTRA LUXE MD, LLC
  SUBSTANTIALLY EQUIVALENT 1
PAIN RELIEF TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PREMIER NORTH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
PRETIKA CORPORATION
  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
  SUBSTANTIALLY EQUIVALENT 1
XTREEM PULSE LLC
  SUBSTANTIALLY EQUIVALENT 1
XTREEM PULSE, LLC
  SUBSTANTIALLY EQUIVALENT 1
YA-MAN LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIIP, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIIP,LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 5 5
2019 1 1
2020 6 6
2021 6 6
2022 5 5
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Patient-Device Incompatibility 3 3
Insufficient Information 2 2
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 1 1
Device Markings/Labelling Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Output Problem 1 1
Material Discolored 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
Arrhythmia 5 5
Dizziness 4 4
Inflammation 4 4
Pain 4 4
Swelling 3 3
Headache 3 3
Hemorrhage/Bleeding 3 3
Laceration(s) 2 2
Dysphagia/ Odynophagia 2 2
Rash 2 2
Retinal Detachment 2 2
Increased Sensitivity 2 2
Skin Discoloration 1 1
Local Reaction 1 1
Peeling 1 1
Itching Sensation 1 1
Tachycardia 1 1
Blurred Vision 1 1
Burning Sensation 1 1
Hot Flashes/Flushes 1 1
Twitching 1 1
Dyspnea 1 1
Erythema 1 1
Fatigue 1 1
Hair Loss 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1
Chest Pain 1 1
Dry Eye(s) 1 1
Nausea 1 1
Nerve Damage 1 1
Undesired Nerve Stimulation 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Malaise 1 1
Sore Throat 1 1
Loss of consciousness 1 1
Sensitivity of Teeth 1 1
Tooth Fracture 1 1
Neck Pain 1 1
Skin Inflammation 1 1
Sleep Dysfunction 1 1
Chemical Exposure 1 1
No Known Impact Or Consequence To Patient 1 1
Convulsion/Seizure 1 1
Presyncope 1 1
Syncope/Fainting 1 1
Neuralgia 1 1
Swollen Lymph Nodes/Glands 1 1
Eye Pain 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Physical Asymmetry 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ion Genius, Inc. II Mar-01-2012
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