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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device massager, therapeutic, electric
Product CodeISA
Regulation Number 890.5660
Device Class 1


Premarket Reviews
ManufacturerDecision
STORZ MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENERATION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENERATION TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 6 6
2018 2 2
2019 6 6
2020 6 6
2021 3 3
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Fire 3 3
Use of Device Problem 2 2
Temperature Problem 2 2
Insufficient Information 2 2
Patient-Device Incompatibility 2 2
Appropriate Term/Code Not Available 1 1
Unintended Electrical Shock 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Thermal Decomposition of Device 1 1
Burst Container or Vessel 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 5 5
Burn(s) 4 4
Burn, Thermal 4 4
Anxiety 2 2
Full thickness (Third Degree) Burn 2 2
No Known Impact Or Consequence To Patient 2 2
Test Result 1 1
Atrial Fibrillation 1 1
No Code Available 1 1
Breast Discomfort/Pain 1 1
Swelling/ Edema 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Numbness 1 1
Breast Mass 1 1
Palpitations 1 1
Vascular System (Circulation), Impaired 1 1
Superficial (First Degree) Burn 1 1
Edema 1 1
High Blood Pressure/ Hypertension 1 1
Rash 1 1
Scar Tissue 1 1
Seizures 1 1
Skin Irritation 1 1
Swelling 1 1
Tinnitus 1 1
Burning Sensation 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Wahl Clipper Corp II Feb-05-2021
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