TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17	17
Insufficient Information	12	12
Use of Device Problem	5	5
Fire	5	5
Smoking	4	4
Patient-Device Incompatibility	4	4
Overheating of Device	3	3
Appropriate Term/Code Not Available	3	3
Therapeutic or Diagnostic Output Failure	3	3
Excessive Heating	2	2
Patient Device Interaction Problem	2	2
Thermal Decomposition of Device	2	2
Device Operates Differently Than Expected	2	2
Temperature Problem	2	2
Device Emits Odor	2	2
Improper or Incorrect Procedure or Method	2	2
Electro-Static Discharge	1	1
Burst Container or Vessel	1	1
Off-Label Use	1	1
Fluid/Blood Leak	1	1
Labelling, Instructions for Use or Training Problem	1	1
Melted	1	1
Unintended Electrical Shock	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	13	13
Pain	11	11
No Clinical Signs, Symptoms or Conditions	6	6
Partial thickness (Second Degree) Burn	5	5
Not Applicable	5	5
No Known Impact Or Consequence To Patient	4	4
Burn, Thermal	4	4
Insufficient Information	4	4
Tinnitus	4	4
Burning Sensation	3	3
Anxiety	3	3
Numbness	3	3
Full thickness (Third Degree) Burn	3	3
No Code Available	2	2
Electric Shock	2	2
Superficial (First Degree) Burn	2	2
Increased Sensitivity	2	2
Seizures	2	2
Stroke/CVA	2	2
Hearing Impairment	2	2
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Muscle Spasm(s)	1	1
Device Overstimulation of Tissue	1	1
Edema	1	1
Electrocution	1	1
Hair Loss	1	1
Headache	1	1
Skin Discoloration	1	1
Skin Irritation	1	1
Swelling	1	1
Rash	1	1
Scar Tissue	1	1
Scarring	1	1
Obstruction/Occlusion	1	1
Breast Mass	1	1
Post Operative Wound Infection	1	1
Palpitations	1	1
Shaking/Tremors	1	1
Injury	1	1
Depression	1	1
Inadequate Pain Relief	1	1
Reaction	1	1
Tingling	1	1
Cramp(s)	1	1
No Consequences Or Impact To Patient	1	1
Blurred Vision	1	1
Visual Disturbances	1	1
Abrasion	1	1
Atrial Fibrillation	1	1
Swelling/ Edema	1	1
Test Result	1	1
Vascular System (Circulation), Impaired	1	1
Thromboembolism	1	1
Neuralgia	1	1
Unspecified Heart Problem	1	1
Breast Discomfort/Pain	1	1
Vascular Dissection	1	1
No Information	1	1