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TPLC
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show TPLC since
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2024
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Device
massager, therapeutic, electric
Product Code
ISA
Regulation Number
890.5660
Device Class
1
Premarket Reviews
Manufacturer
Decision
BTL INDUSTRIES INC.
SUBSTANTIALLY EQUIVALENT
1
EMS ELECTRO MEDICAL SYSTEMS SA
SUBSTANTIALLY EQUIVALENT
1
MEDISPEC LTD.
SUBSTANTIALLY EQUIVALENT
1
STORZ MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
TISSUE REGENERATION TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
TISSUE REGENERATION TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
TISSUE REGENERATION TECHNOLOGIES, LLC DBA AS SOFTWAVE TRT
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
6
6
2016
12
12
2017
6
6
2018
2
2
2019
6
6
2020
6
6
2021
3
3
2022
8
8
2023
14
14
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
16
16
Insufficient Information
9
9
Patient-Device Incompatibility
4
4
Fire
4
4
Use of Device Problem
4
4
Smoking
3
3
Therapeutic or Diagnostic Output Failure
3
3
Appropriate Term/Code Not Available
2
2
Device Operates Differently Than Expected
2
2
Temperature Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Device Emits Odor
2
2
Overheating of Device
2
2
Thermal Decomposition of Device
2
2
Patient Device Interaction Problem
2
2
Excessive Heating
2
2
Unintended Electrical Shock
1
1
Burst Container or Vessel
1
1
Labelling, Instructions for Use or Training Problem
1
1
Melted
1
1
Off-Label Use
1
1
Electro-Static Discharge
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
12
12
Pain
10
10
Partial thickness (Second Degree) Burn
5
5
Not Applicable
5
5
Insufficient Information
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Burn, Thermal
4
4
Numbness
3
3
Anxiety
3
3
Tinnitus
3
3
Seizures
2
2
Stroke/CVA
2
2
Burning Sensation
2
2
Electric Shock
2
2
Full thickness (Third Degree) Burn
2
2
Increased Sensitivity
2
2
No Code Available
2
2
Superficial (First Degree) Burn
2
2
No Known Impact Or Consequence To Patient
2
2
Test Result
1
1
Neuralgia
1
1
Unspecified Heart Problem
1
1
Breast Discomfort/Pain
1
1
Swelling/ Edema
1
1
Vascular Dissection
1
1
Atrial Fibrillation
1
1
Vascular System (Circulation), Impaired
1
1
Thromboembolism
1
1
Breast Mass
1
1
Post Operative Wound Infection
1
1
Palpitations
1
1
Shaking/Tremors
1
1
Tingling
1
1
Cramp(s)
1
1
No Consequences Or Impact To Patient
1
1
Injury
1
1
Depression
1
1
Inadequate Pain Relief
1
1
Reaction
1
1
Edema
1
1
Electrocution
1
1
Hair Loss
1
1
Headache
1
1
Hearing Impairment
1
1
Hypersensitivity/Allergic reaction
1
1
High Blood Pressure/ Hypertension
1
1
Muscle Spasm(s)
1
1
Device Overstimulation of Tissue
1
1
Skin Discoloration
1
1
Skin Irritation
1
1
Swelling
1
1
Blurred Vision
1
1
Visual Disturbances
1
1
Rash
1
1
Scar Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Wahl Clipper Corp
II
Feb-05-2021
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