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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
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 1
MEDISPEC LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENERATION TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENERATION TECHNOLOGIES, LLC DBA AS SOFTWAVE TRT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 6 6
2021 3 3
2022 8 8
2023 14 14
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 4 4
Fire 3 3
Smoking 3 3
Therapeutic or Diagnostic Output Failure 3 3
Use of Device Problem 3 3
Patient-Device Incompatibility 2 2
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 2 2
Excessive Heating 2 2
Temperature Problem 2 2
Off-Label Use 1 1
Unintended Electrical Shock 1 1
Thermal Decomposition of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 10 10
No Clinical Signs, Symptoms or Conditions 6 6
Bruise/Contusion 4 4
Tinnitus 4 4
Partial thickness (Second Degree) Burn 4 4
Swelling/ Edema 4 4
Burn(s) 4 4
Insufficient Information 4 4
Burn, Thermal 3 3
Hearing Impairment 2 2
Increased Sensitivity 2 2
Full thickness (Third Degree) Burn 2 2
Unspecified Tissue Injury 2 2
Anxiety 2 2
Burning Sensation 2 2
Discomfort 2 2
Numbness 2 2
Breast Discomfort/Pain 1 1
Neuralgia 1 1
Thromboembolism 1 1
Inadequate Pain Relief 1 1
No Consequences Or Impact To Patient 1 1
Unspecified Heart Problem 1 1
Vascular System (Circulation), Impaired 1 1
Shaking/Tremors 1 1
Reaction 1 1
Scar Tissue 1 1
Hair Loss 1 1
Swelling 1 1
Erectile Dysfunction 1 1
Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Palpitations 1 1
Post Operative Wound Infection 1 1
Device Overstimulation of Tissue 1 1
Obstruction/Occlusion 1 1
Edema 1 1
Atrial Fibrillation 1 1
Hematoma 1 1
Vascular Dissection 1 1
Test Result 1 1
Urinary Incontinence 1 1
Diaphoresis 1 1
Emotional Changes 1 1
Electric Shock 1 1
Breast Mass 1 1
Stroke/CVA 1 1
Superficial (First Degree) Burn 1 1
High Blood Pressure/ Hypertension 1 1

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