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TPLC
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show TPLC since
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Device
stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
Product Code
IMG
Regulation Number
890.5860
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACCELERATED CARE PLUS (ACP)
SUBSTANTIALLY EQUIVALENT
1
BTL INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
4
4
2016
7
7
2017
3
3
2019
14
14
2020
10
10
2021
13
13
2022
14
14
2023
7
7
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
27
27
Break
7
7
Intermittent Energy Output
6
6
Insufficient Information
6
6
Electrical /Electronic Property Problem
5
5
Loss of or Failure to Bond
4
4
Energy Output Problem
3
3
Overheating of Device
3
3
Unintended Electrical Shock
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Temperature Problem
2
2
Use of Device Problem
2
2
Sparking
1
1
Material Split, Cut or Torn
1
1
Physical Property Issue
1
1
No Apparent Adverse Event
1
1
Device Operates Differently Than Expected
1
1
Excessive Heating
1
1
Improper or Incorrect Procedure or Method
1
1
Device Displays Incorrect Message
1
1
Noise, Audible
1
1
Nonstandard Device
1
1
Device Inoperable
1
1
Output Problem
1
1
Material Integrity Problem
1
1
Smoking
1
1
Output above Specifications
1
1
Microbial Contamination of Device
1
1
Degraded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
15
15
No Clinical Signs, Symptoms or Conditions
8
8
Superficial (First Degree) Burn
7
7
Partial thickness (Second Degree) Burn
7
7
Electric Shock
6
6
No Known Impact Or Consequence To Patient
6
6
No Consequences Or Impact To Patient
6
6
Full thickness (Third Degree) Burn
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Shock from Patient Lead(s)
2
2
Scarring
2
2
Burn, Thermal
2
2
Injury
2
2
Swelling
2
2
Discomfort
2
2
Pain
2
2
Lead(s), Burn(s) From
2
2
Patient Problem/Medical Problem
1
1
Fungal Infection
1
1
No Code Available
1
1
Device Overstimulation of Tissue
1
1
Post Traumatic Wound Infection
1
1
Rash
1
1
Chest Pain
1
1
Erythema
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Skin Tears
1
1
Deformity/ Disfigurement
1
1
Tissue Breakdown
1
1
Ambulation Difficulties
1
1
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