TPLC - Total Product Life Cycle

show TPLC since

Device	massager, therapeutic, electric
Regulation Description	Therapeutic massager.
Product Code	ISA
Regulation Number	890.5660
Device Class	1

Premarket Reviews
Manufacturer	Decision
BTL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
E.M.S ELECTRO MEDICAL SYSTEMS S.A
	SUBSTANTIALLY EQUIVALENT	1
MEDISPEC, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STORZ MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
TERMOSALUD
	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	16	16
Insufficient Information	10	10
Smoking	5	5
Fire	4	4
Use of Device Problem	4	4
Patient-Device Incompatibility	3	3
Therapeutic or Diagnostic Output Failure	3	3
Appropriate Term/Code Not Available	3	3
Overheating of Device	3	3
Patient Device Interaction Problem	2	2
Excessive Heating	2	3
Temperature Problem	2	2
Burst Container or Vessel	1	1
Off-Label Use	1	1
Image Display Error/Artifact	1	1
Unintended Electrical Shock	1	1
Thermal Decomposition of Device	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Emits Odor	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	15	15
No Clinical Signs, Symptoms or Conditions	9	9
Partial thickness (Second Degree) Burn	7	7
Burn(s)	7	7
Swelling/ Edema	5	5
Insufficient Information	5	6
Bruise/Contusion	4	4
Tinnitus	4	4
Numbness	4	4
Burn, Thermal	4	4
Superficial (First Degree) Burn	3	3
Stroke/CVA	3	3
Burning Sensation	3	3
Increased Sensitivity	2	2
Full thickness (Third Degree) Burn	2	2
Unspecified Tissue Injury	2	2
Anxiety	2	2
Scar Tissue	2	2
Discomfort	2	2
Rash	2	2
No Known Impact Or Consequence To Patient	2	2
Hearing Impairment	2	2
Unintended Radiation Exposure	1	1
Breast Discomfort/Pain	1	1
Ambulation Difficulties	1	1
High Blood Pressure/ Hypertension	1	1
Neuralgia	1	1
Neuropathy	1	1
Hemothorax	1	1
Thromboembolism	1	1
Inadequate Pain Relief	1	1
No Consequences Or Impact To Patient	1	1
Sleep Dysfunction	1	1
Unspecified Heart Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Breast Mass	1	1
Electric Shock	1	1
Vascular System (Circulation), Impaired	1	1
Shaking/Tremors	1	1
Emotional Changes	1	1
Reaction	1	1
Seizures	1	1
Skin Irritation	1	1
Hair Loss	1	1
Brain Injury	1	1
Diaphoresis	1	1
No Code Available	1	1
Swelling	1	1
Nerve Damage	1	1
Erectile Dysfunction	1	1