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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
Product CodeIMG
Regulation Number 890.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCELERATED CARE PLUS (ACP)
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
DR. OLIVER WENKER, M.D., M.B.A.
  SUBSTANTIALLY EQUIVALENT 1
JOHARI DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER MEDIZINSYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 4 4
2016 7 7
2017 3 3
2019 14 14
2020 10 10
2021 13 13
2022 14 14
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24 24
Break 7 7
Insufficient Information 7 7
Intermittent Energy Output 6 6
Electrical /Electronic Property Problem 5 5
Overheating of Device 4 4
Loss of or Failure to Bond 4 4
Energy Output Problem 3 3
Use of Device Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Temperature Problem 2 2
Unintended Electrical Shock 2 2
Excessive Heating 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Smoking 1 1
Device Inoperable 1 1
Nonstandard Device 1 1
Degraded 1 1
Improper or Incorrect Procedure or Method 1 1
Microbial Contamination of Device 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Device Operates Differently Than Expected 1 1
Material Integrity Problem 1 1
Output above Specifications 1 1
Output Problem 1 1
Physical Property Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 13 13
Partial thickness (Second Degree) Burn 7 7
Superficial (First Degree) Burn 7 7
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 6 6
Full thickness (Third Degree) Burn 6 6
Electric Shock 6 6
No Consequences Or Impact To Patient 6 6
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Lead(s), Burn(s) From 2 2
Shock from Patient Lead(s) 2 2
Scarring 2 2
Swelling 2 2
Discomfort 2 2
Burn, Thermal 2 2
Injury 2 2
Deformity/ Disfigurement 1 1
Fungal Infection 1 1
Obstruction/Occlusion 1 1
Post Traumatic Wound Infection 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Complaint, Ill-Defined 1 1
Rash 1 1
Chest Pain 1 1
Erythema 1 1
Nausea 1 1
Device Overstimulation of Tissue 1 1
No Code Available 1 1
Insufficient Information 1 1
Abdominal Distention 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1

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