TPLC - Total Product Life Cycle

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Device	stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
Regulation Description	Ultrasound and muscle stimulator.
Product Code	IMG
Regulation Number	890.5860
Device Class	2

Premarket Reviews
Manufacturer	Decision
XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	21	21
Patient Device Interaction Problem	6	6
Break	4	4
Electrical /Electronic Property Problem	3	3
Energy Output Problem	3	5
Use of Device Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Temperature Problem	2	2
Insufficient Information	2	2
Loss of or Failure to Bond	2	2
Intermittent Energy Output	1	1
Excessive Heating	1	1
Noise, Audible	1	3
No Apparent Adverse Event	1	1
Smoking	1	3
Output Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Microbial Contamination of Device	1	1
Device Displays Incorrect Message	1	1
Output above Specifications	1	1
Overheating of Device	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	20	20
Superficial (First Degree) Burn	7	7
No Clinical Signs, Symptoms or Conditions	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Electric Shock	3	3
Shock from Patient Lead(s)	2	2
Partial thickness (Second Degree) Burn	2	2
Full thickness (Third Degree) Burn	2	4
Fungal Infection	1	1
Skin Inflammation/ Irritation	1	1
Device Overstimulation of Tissue	1	1
Rash	1	1
Erythema	1	1
Insufficient Information	1	1
Skin Tears	1	1
Tissue Breakdown	1	1
Ambulation Difficulties	1	1