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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, muscle, powered
Product CodeIPF
Regulation Number 890.5850
Device Class 2


Premarket Reviews
ManufacturerDecision
ASTEK TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIGITIMER LTD.
  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 5
FIRSTKIND LTD
  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
MYOWORX INC.
  SUBSTANTIALLY EQUIVALENT 1
NCS LAB SRL
  SUBSTANTIALLY EQUIVALENT 2
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 3
STORZ MEDICAL AG
  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
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 10 10
2020 13 13
2021 2 2
2022 4 4
2023 6 6

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
Inappropriate/Inadequate Shock/Stimulation 2 2
Patient-Device Incompatibility 2 2
Electrical /Electronic Property Problem 2 2
Energy Output Problem 2 2
Product Quality Problem 2 2
No Apparent Adverse Event 2 2
Unintended Electrical Shock 2 2
Output Problem 2 2
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Separation 1 1
Power Conditioning Problem 1 1
Mechanical Problem 1 1
Break 1 1
Unintended Power Up 1 1
Connection Problem 1 1
Failure to Shut Off 1 1
Inadequacy of Device Shape and/or Size 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
Superficial (First Degree) Burn 6 6
No Known Impact Or Consequence To Patient 5 5
Electric Shock 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 3 3
Shock 2 2
Insufficient Information 2 2
Burn, Thermal 2 2
Ambulation Difficulties 1 1
Tachycardia 1 1
Burning Sensation 1 1
Tingling 1 1
Cardiac Arrest 1 1
Headache 1 1
Inflammation 1 1
Muscle Spasm(s) 1 1
Muscular Rigidity 1 1
Undesired Nerve Stimulation 1 1
Device Overstimulation of Tissue 1 1
Anxiety 1 1
Discomfort 1 1
Injury 1 1
Numbness 1 1
Loss of consciousness 1 1
Full thickness (Third Degree) Burn 1 1
Lead(s), Burn(s) From 1 1
Shock from Patient Lead(s) 1 1
Muscle/Tendon Damage 1 1

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