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TPLC
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Device
stimulator, transcutaneous electrical, aesthetic purposes
Product Code
NFO
Regulation Number
882.5890
Device Class
2
Premarket Reviews
Manufacturer
Decision
21 EQUIPMENT S.R.L.
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
1
CAROL COLE COMPANY DBA NUFACE
SUBSTANTIALLY EQUIVALENT
3
CAROLE COLE COMPANY
SUBSTANTIALLY EQUIVALENT
1
FOREO, INC.
SUBSTANTIALLY EQUIVALENT
1
JOHARI DIGITAL HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
MICRO CURRENT TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
3
NSE PRODUCTS, INC
SUBSTANTIALLY EQUIVALENT
1
PREMIER NORTH AMERICA INC.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN DJ MEDICAL EQUIPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
THERAGUN, 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
MDR Year
MDR Reports
MDR Events
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
7
7
Patient-Device Incompatibility
3
3
Patient Device Interaction Problem
2
2
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
4
4
Inflammation
4
4
Headache
3
3
Hemorrhage/Bleeding
3
3
Dizziness
3
3
Pain
3
3
Swelling
3
3
Increased Sensitivity
2
2
Dysphagia/ Odynophagia
2
2
Laceration(s)
2
2
Nausea
1
1
Nerve Damage
1
1
Undesired Nerve Stimulation
1
1
Itching Sensation
1
1
Atrial Fibrillation
1
1
Bradycardia
1
1
Dyspnea
1
1
Fatigue
1
1
Hair Loss
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
Neck Pain
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
Skin Discoloration
1
1
Tachycardia
1
1
Blurred Vision
1
1
Burning Sensation
1
1
Twitching
1
1
Rash
1
1
Local Reaction
1
1
Retinal Detachment
1
1
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