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
Insufficient Device Problem Information	10	10
Adverse Event Without Identified Device or Use Problem	6	6
Overheating of Device	6	6
Use of Device Problem	3	3
Smoking	3	3
Excessive Heating	2	3
Appropriate Device Problem Term/Code Not Available	2	2
Therapeutic or Diagnostic Output Failure	2	2
Temperature Problem	1	1
Fire	1	1
Patient Device Interaction Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Image Display Error/Artifact	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
Pain	12	12
Partial thickness (Second Degree) Burn	11	11
Unspecified Tissue Injury	5	5
Swelling/ Edema	5	5
Superficial (First Degree) Burn	5	5
Insufficient Information	5	6
Burn(s)	5	5
Bruise/Contusion	4	4
Numbness	4	4
Tinnitus	4	4
Burning Sensation	3	3
Stroke/CVA	3	3
Discomfort	2	2
Hearing Impairment	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Hyperresponsive to stimuli	2	2
Unspecified Infection	2	2
Scar Tissue	2	2
Skin Inflammation/ Irritation	2	2
Bacteremia	2	2
Ear Pain	2	2
Neuropathy	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Neuralgia	1	1
Device Overstimulation of Tissue	1	1
Nerve Damage	1	1
Anxiety	1	1
Edema	1	1
Brain Injury	1	1
Rash	1	1
Sleep Dysfunction	1	1
Diaphoresis	1	1
Inflammation	1	1
Head Injury	1	1
Limb Pain	1	1
Erectile Dysfunction	1	1
Foreign Body Reaction	1	1
Ambulation or Postural Difficulties	1	1
Emotional Changes	1	1
Unspecified Heart Problem	1	1
Urinary Incontinence	1	1
Aortic dissection	1	1
Breast Discomfort/Pain	1	1
Obstruction/Occlusion	1	1
Autoimmune Disorder	1	1
Itching Sensation	1	1
Vascular Dissection	1	1
Hematoma	1	1
Unintended Radiation Exposure	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