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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device massager, vacuum, radio frequency induced heat
Definition Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
Product CodePBX
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
21 EQUIPMENT S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAPENERGY MEDICAL S.L.
  SUBSTANTIALLY EQUIVALENT 1
CAPENERGY MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE LLC
  SUBSTANTIALLY EQUIVALENT 1
EL..EN. ELECTROIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL.EN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS SPORT AND HEALTH TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK LLC.
  SUBSTANTIALLY EQUIVALENT 1
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 1
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 2
LUVO MEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MECTRONIC MEDICALE S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
NEAUVIA NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
SWIMS AMERICA CORP
  SUBSTANTIALLY EQUIVALENT 3
TERMOSALUD
  SUBSTANTIALLY EQUIVALENT 2
VENUS CONCEPT USA INC.
  SUBSTANTIALLY EQUIVALENT 5
VIORA LTD.
  SUBSTANTIALLY EQUIVALENT 3
WEERO CO.
  SUBSTANTIALLY EQUIVALENT 1
WINTECARE SA
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 4 4
2021 8 8
2022 7 7
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 12
Insufficient Information 5 5
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Energy Output Problem 2 2
Product Quality Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Detachment of Device or Device Component 1 1
Electrical Shorting 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Excessive Heating 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 7 7
Full thickness (Third Degree) Burn 5 5
Burn(s) 5 5
Scar Tissue 3 3
Superficial (First Degree) Burn 3 3
Skin Infection 3 3
Swelling/ Edema 2 2
Skin Burning Sensation 2 2
Nerve Damage 2 2
Pain 2 2
Skin Discoloration 2 2
Deformity/ Disfigurement 2 2
Tissue Breakdown 1 1
Dizziness 1 1
Injury 1 1
Syncope/Fainting 1 1
Paresthesia 1 1
Unspecified Vascular Problem 1 1
Unspecified Reproductive System or Breast Problem 1 1
Scarring 1 1
Chest Pain 1 1
Erythema 1 1
Fall 1 1
Hematoma 1 1
Inflammation 1 1
Nausea 1 1
Localized Skin Lesion 1 1
Skin Disorders 1 1
Patient Problem/Medical Problem 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Subcutaneous Nodule 1 1

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