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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
ACTEGY LTD
  SUBSTANTIALLY EQUIVALENT 1
AMPCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARP MANUFACTURING, INC
  SUBSTANTIALLY EQUIVALENT 1
ASTEK TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-MEDICAL RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 2
BTL INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DIGITIMER LTD.
  SUBSTANTIALLY EQUIVALENT 1
DJO, LLC
  SUBSTANTIALLY EQUIVALENT 4
EGZOTECH SP. Z O. O.
  SUBSTANTIALLY EQUIVALENT 1
EL. EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL.EN. S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRONIC WAVEFORM LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELITE MEDICAL SUPPLY OF NEW YORK, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMPI
  SUBSTANTIALLY EQUIVALENT 1
EMSI
  SUBSTANTIALLY EQUIVALENT 2
EMSI, INC.
  SUBSTANTIALLY EQUIVALENT 1
ESWALLOW USA
  SUBSTANTIALLY EQUIVALENT 1
FAMIDOC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FIRSTKIND LIMITED
  SUBSTANTIALLY EQUIVALENT 9
FIRSTKIND LTD
  SUBSTANTIALLY EQUIVALENT 1
FLOWAID MEDICAL TECHNOLOGIES, CORP
  SUBSTANTIALLY EQUIVALENT 1
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
G.TEC MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
HILLTEK LLC
  SUBSTANTIALLY EQUIVALENT 1
IBRAMED EQUIPAMENTOS MEDICOS
  SUBSTANTIALLY EQUIVALENT 3
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDLANDER MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
METRON MEDICAL AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
METTLER ELECTRONICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MYOWORX INC.
  SUBSTANTIALLY EQUIVALENT 1
NCS LAB SRL
  SUBSTANTIALLY EQUIVALENT 2
NEUROTRIGGER
  SUBSTANTIALLY EQUIVALENT 1
NIVEUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OTTO BOCK, AUSTRIA GMBH
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1
PHYSIOMED ELEKTROMEDIZIN AG
  SUBSTANTIALLY EQUIVALENT 1
REHABTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
REMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RESTORATIVE THERAPIES INC.
  SUBSTANTIALLY EQUIVALENT 1
RS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SELECTIVEMED COMPONENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHEAR STRESS THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN KONMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN XFT MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SMARTMISSIMO TECHNOLOGIES PTE LTD
  SUBSTANTIALLY EQUIVALENT 3
STIMEL LTD
  SUBSTANTIALLY EQUIVALENT 1
STIMMED, LLC
  SUBSTANTIALLY EQUIVALENT 2
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
TONE-A-MATIC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UMEHEAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
VALMED, SA
  SUBSTANTIALLY EQUIVALENT 1
VISION QUEST INDUSTRIES INC./DBA VQ ORTHOCARE
  SUBSTANTIALLY EQUIVALENT 1
VISION QUEST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZYNEX MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ZYNEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 19 19
2015 11 11
2016 8 8
2017 2 2
2018 3 3
2019 10 10
2020 13 13
2021 2 2
2022 4 4
2023 8 8
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Temperature Problem 10 10
Device Operates Differently Than Expected 10 10
Charred 9 9
Scratched Material 6 6
Use of Device Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Insufficient Information 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Intermittent Energy Output 4 4
Electrical /Electronic Property Problem 3 3
Patient-Device Incompatibility 3 3
Failure to Shut Off 2 2
Unintended Electrical Shock 2 2
No Apparent Adverse Event 2 2
Output Problem 2 2
Device Emits Odor 2 2
Energy Output Problem 2 2
Device Inoperable 2 2
Product Quality Problem 2 2
Self-Activation or Keying 1 1
Material Separation 1 1
Unintended Power Up 1 1
Break 1 1
Inadequacy of Device Shape and/or Size 1 1
Overheating of Device 1 1
Power Conditioning Problem 1 1
Fracture 1 1
Mechanical Problem 1 1
Melted 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Connection Problem 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 10 10
Pain 9 9
Electric Shock 8 8
Superficial (First Degree) Burn 8 8
Burn(s) 7 7
No Information 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Erythema 4 4
Headache 3 3
Burn, Thermal 3 3
Injury 3 3
Shock 3 3
Shock from Patient Lead(s) 3 3
Insufficient Information 2 2
Full thickness (Third Degree) Burn 2 2
Burning Sensation 2 2
Scarring 2 2
Device Overstimulation of Tissue 2 2
Wound Dehiscence 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Dyspnea 1 1
Inflammation 1 1
Laceration(s) 1 1
Muscle Spasm(s) 1 1
Muscular Rigidity 1 1
Nerve Damage 1 1
Undesired Nerve Stimulation 1 1
Tingling 1 1
Anxiety 1 1
Discomfort 1 1
Swelling 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Arthralgia 1 1
Numbness 1 1
Loss of consciousness 1 1
Ambulation Difficulties 1 1
No Patient Involvement 1 1
Lead(s), Burn(s) From 1 1
Fluid Discharge 1 1
No Code Available 1 1
Muscle/Tendon Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 International Rehabilitative Sciences, Inc. II Nov-08-2010
2 Ion Genius, Inc. II Mar-01-2012
3 Liberty Medical Solutions, LLC II Dec-07-2023
4 Zynex Medical, Inc. II Jun-26-2014
5 eSwallow USA LLC II Jul-25-2011
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