TPLC - Total Product Life Cycle

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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
TERMOSALUD
	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	10	10
Insufficient Information	8	8
Use of Device Problem	5	5
Smoking	4	4
Therapeutic or Diagnostic Output Failure	3	3
Patient-Device Incompatibility	2	2
Patient Device Interaction Problem	2	2
Appropriate Term/Code Not Available	2	2
Excessive Heating	2	3
Overheating of Device	2	2
Fire	1	1
Off-Label Use	1	1
Image Display Error/Artifact	1	1
Unintended Electrical Shock	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	12	12
No Clinical Signs, Symptoms or Conditions	9	9
Partial thickness (Second Degree) Burn	8	8
Swelling/ Edema	5	5
Insufficient Information	5	6
Burn(s)	5	5
Bruise/Contusion	4	4
Tinnitus	4	4
Numbness	4	4
Superficial (First Degree) Burn	3	3
Stroke/CVA	3	3
Unspecified Tissue Injury	3	3
Burning Sensation	3	3
Increased Sensitivity	2	2
Scar Tissue	2	2
Discomfort	2	2
Hearing Impairment	2	2
Head Injury	1	1
Hematoma	1	1
Inflammation	1	1
Edema	1	1
Obstruction/Occlusion	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Skin Disorders	1	1
Autoimmune Disorder	1	1
Device Overstimulation of Tissue	1	1
Post Operative Wound Infection	1	1
Skin Inflammation/ Irritation	1	1
Rash	1	1
Vascular Dissection	1	1
Erectile Dysfunction	1	1
Nerve Damage	1	1
Urinary Incontinence	1	1
Diaphoresis	1	1
Brain Injury	1	1
Hair Loss	1	1
Emotional Changes	1	1
Electric Shock	1	1
Anxiety	1	1
Shaking/Tremors	1	1
Breast Mass	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Sleep Dysfunction	1	1
Unspecified Heart Problem	1	1
Neuropathy	1	1
Inadequate Pain Relief	1	1
Thromboembolism	1	1
Hemothorax	1	1
Neuralgia	1	1
Unspecified Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Pivotal Health Solutions, Inc.	II	Nov-24-2025
2	Richard Wolf GmbH	II	May-13-2025
3	Wahl Clipper Corp	II	Feb-05-2021