TPLC - Total Product Life Cycle

• Device: stimulator, muscle, powered
• Regulation Description: Powered muscle stimulator.
• Product Code: IPF
• Regulation Number: 890.5850
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BTL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
CYMEDICA ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EGZOTECH SP. Z O. O.
	SUBSTANTIALLY EQUIVALENT	1
EL.EN S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
EMSI, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENRAF-NONIUS, B.V.
	SUBSTANTIALLY EQUIVALENT	1
FIRSTKIND LIMITED
	SUBSTANTIALLY EQUIVALENT	2
FOTONA D.O.O.
	SUBSTANTIALLY EQUIVALENT	1
HILLTEK, LLC
	SUBSTANTIALLY EQUIVALENT	1
IBRAMED EQUIPAMENTOS MEDICOS
	SUBSTANTIALLY EQUIVALENT	1
INMODE , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLANDER MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
METTLER ELECTRONICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MYOWORX, INC.
	SUBSTANTIALLY EQUIVALENT	1
NCS LAB SRL
	SUBSTANTIALLY EQUIVALENT	2
NEUROTRIGGER
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	1
QUANTUMTX PTE. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
REHABTRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
REMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ROUNDWHALE TECHNOLOGY CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XFT MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SMARTMISSIMO TECHNOLOGIES PTE, LTD.
	SUBSTANTIALLY EQUIVALENT	2
STORZ MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
SUNMED, LLC
	SUBSTANTIALLY EQUIVALENT	1
SWIMS AMERICA CORP
	SUBSTANTIALLY EQUIVALENT	1
THOUGHT TECHNOLOGY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
TIMEWAVER PRODUCTION GMBH
	SUBSTANTIALLY EQUIVALENT	1
TRAINFES
	SUBSTANTIALLY EQUIVALENT	1
WEERO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZYNEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	3	3
2022	4	4
2023	8	8
2024	5	5
2025	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4	4
Use of Device Problem	3	3
Crack	2	2
Insufficient Information	2	2
Patient Device Interaction Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Melted	2	2
Electrical /Electronic Property Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Material Frayed	1	1
Break	1	1
Output Problem	1	1
Unintended Power Up	1	1
Patient-Device Incompatibility	1	1
Smoking	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Fracture	1	1
Overheating of Device	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Superficial (First Degree) Burn	5	5
No Clinical Signs, Symptoms or Conditions	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Insufficient Information	3	3
Pain	3	3
Partial thickness (Second Degree) Burn	3	3
Electric Shock	2	2
Scar Tissue	2	2
Full thickness (Third Degree) Burn	2	2
Arrhythmia	1	1
Arthralgia	1	1
Emotional Changes	1	1
Fatigue	1	1
Shock from Patient Lead(s)	1	1
Aspiration/Inhalation	1	1
Inflammation	1	1
Cardiac Arrest	1	1
Device Overstimulation of Tissue	1	1
Palpitations	1	1
Burn(s)	1	1
Burning Sensation	1	1
Vomiting	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1
Undesired Nerve Stimulation	1	1
Unspecified Heart Problem	1	1
Headache	1	1
Eye Pain	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Liberty Medical Solutions, LLC	II	Dec-07-2023