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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device massager, vacuum, radio frequency induced heat
Regulation Description Electrosurgical cutting and coagulation device and accessories.
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
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAPENERGY MEDICAL S.L.
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EL.EN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL.EN S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
EMA AESTHETICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL VIBRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS SPORT AND HEALTH TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GOLDEN STAR SRL
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK
  SUBSTANTIALLY EQUIVALENT 1
HEAT IN A CLICK, LLC
  SUBSTANTIALLY EQUIVALENT 1
INDIBA S. A. U.
  SUBSTANTIALLY EQUIVALENT 2
INMODE , LTD.
  SUBSTANTIALLY EQUIVALENT 2
LUVO MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MECTRONIC MEDICALE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
NEAUVIA NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
NOVASONIX TECHNOLOGY S.L.
  SUBSTANTIALLY EQUIVALENT 1
POLLOGEN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
S&M MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SWIMS AMERICA CORP
  SUBSTANTIALLY EQUIVALENT 3
TERMOSALUD
  SUBSTANTIALLY EQUIVALENT 2
TERMOSALUD S.L.
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
VIORA , LTD.
  SUBSTANTIALLY EQUIVALENT 3
WEERO CO.
  SUBSTANTIALLY EQUIVALENT 1
WEERO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XOD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 4 4
2021 8 11
2022 7 7
2023 7 7
2024 2 2
2025 4 4
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Insufficient Information 6 6
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 4 4
Patient Device Interaction Problem 3 4
Output Problem 2 4
Unclear Information 2 2
Energy Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Radiation Leak 1 1
Product Quality Problem 1 1
Grounding Malfunction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Full thickness (Third Degree) Burn 9 9
Burn(s) 7 7
Partial thickness (Second Degree) Burn 5 5
Blister 4 4
Superficial (First Degree) Burn 3 5
Skin Infection 3 3
Nerve Damage 3 3
Pain 3 3
Scar Tissue 3 3
Deformity/ Disfigurement 3 4
Skin Discoloration 2 2
Paresthesia 2 2
Swelling/ Edema 2 2
Skin Burning Sensation 2 2
Syncope/Fainting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Nausea 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Dizziness 1 1
Hematoma 1 1
Inflammation 1 1
Scarring 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Localized Skin Lesion 1 1
Skin Disorders 1 2
Burning Sensation 1 1
Chest Pain 1 1
Erythema 1 1
Fall 1 1
Unspecified Tissue Injury 1 1
Unspecified Vascular Problem 1 1
Subcutaneous Nodule 1 1
Tissue Breakdown 1 1
Unspecified Reproductive System or Breast Problem 1 1
Unintended Radiation Exposure 1 1

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