TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ASTEK TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	1
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. ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL.EN. S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
EMSI, INC.
	SUBSTANTIALLY EQUIVALENT	1
FIRSTKIND LIMITED
	SUBSTANTIALLY EQUIVALENT	4
FOTONA D.O.O.
	SUBSTANTIALLY EQUIVALENT	1
G.TEC MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	1
HILLTEK LLC
	SUBSTANTIALLY EQUIVALENT	1
IBRAMED EQUIPAMENTOS MEDICOS
	SUBSTANTIALLY EQUIVALENT	1
INMODE LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDLANDER MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES 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
REHABTRONICS INC.
	SUBSTANTIALLY EQUIVALENT	1
REMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHEAR STRESS THERAPEUTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN KONMED TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XFT MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	2
SMARTMISSIMO TECHNOLOGIES PTE LTD
	SUBSTANTIALLY EQUIVALENT	2
STORZ MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
SUNMED LLC.
	SUBSTANTIALLY EQUIVALENT	1
SWIMS AMERICA CORP
	SUBSTANTIALLY EQUIVALENT	1
THERASIGMA, LLC
	SUBSTANTIALLY EQUIVALENT	1
THOUGHT TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	1
TIMEWAVER PRODUCTION GMBH
	SUBSTANTIALLY EQUIVALENT	1
UMEHEAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
VISION QUEST INDUSTRIES INC./DBA VQ ORTHOCARE
	SUBSTANTIALLY EQUIVALENT	1
WEERO CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZYNEX MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	10	10
2020	13	13
2021	2	2
2022	4	4
2023	8	8
2024	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6	6
Intermittent Energy Output	4	4
Use of Device Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Unintended Electrical Shock	2	2
Energy Output Problem	2	2
Patient-Device Incompatibility	2	2
Product Quality Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
No Apparent Adverse Event	2	2
Electrical /Electronic Property Problem	2	2
Failure to Shut Off	1	1
Break	1	1
Mechanical Problem	1	1
Output Problem	1	1
Unintended Power Up	1	1
Smoking	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Power Conditioning Problem	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Fracture	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Superficial (First Degree) Burn	7	7
Pain	6	6
Electric Shock	5	5
No Clinical Signs, Symptoms or Conditions	4	4
No Known Impact Or Consequence To Patient	4	4
Insufficient Information	3	3
No Consequences Or Impact To Patient	3	3
Burn, Thermal	2	2
Burning Sensation	2	2
Headache	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Arthralgia	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
Injury	1	1
Muscle Spasm(s)	1	1
Vomiting	1	1
Discomfort	1	1
Numbness	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1
Undesired Nerve Stimulation	1	1
Shock	1	1
Tachycardia	1	1
Anxiety	1	1
Loss of consciousness	1	1
Lead(s), Burn(s) From	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