Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
Product Code
IMG
Regulation Number
890.5860
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
14
14
2020
10
10
2021
13
13
2022
14
14
2023
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
16
16
Break
7
7
Intermittent Energy Output
6
6
Electrical /Electronic Property Problem
5
5
Loss of or Failure to Bond
4
4
Energy Output Problem
3
3
Use of Device Problem
2
2
Overheating of Device
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Temperature Problem
2
2
Unintended Electrical Shock
2
2
Excessive Heating
1
1
Insufficient Information
1
1
Noise, Audible
1
1
Material Split, Cut or Torn
1
1
Smoking
1
1
Output Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Microbial Contamination of Device
1
1
Device Displays Incorrect Message
1
1
Sparking
1
1
Output above Specifications
1
1
Nonstandard Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Superficial (First Degree) Burn
7
7
No Clinical Signs, Symptoms or Conditions
7
7
Electric Shock
6
6
No Known Impact Or Consequence To Patient
6
6
Burn(s)
6
6
No Consequences Or Impact To Patient
6
6
Partial thickness (Second Degree) Burn
5
5
Full thickness (Third Degree) Burn
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Shock from Patient Lead(s)
2
2
No Code Available
1
1
Insufficient Information
1
1
Lead(s), Burn(s) From
1
1
No Patient Involvement
1
1
Tissue Breakdown
1
1
Patient Problem/Medical Problem
1
1
Fungal Infection
1
1
Skin Tears
1
1
Ambulation Difficulties
1
1
Erythema
1
1
Device Overstimulation of Tissue
1
1
Rash
1
1
Scarring
1
1
Swelling
1
1
-
-