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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device stimulator, muscle, powered
Regulation Description Powered muscle stimulator.
Product CodeIPF
Regulation Number 890.5850
Device Class 2


Premarket Reviews
ManufacturerDecision
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIGITIMER LTD.
  SUBSTANTIALLY EQUIVALENT 1
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
ELITE MEDICAL SUPPLY OF NEW YORK, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIRSTKIND LIMITED
  SUBSTANTIALLY EQUIVALENT 6
FIRSTKIND LTD
  SUBSTANTIALLY EQUIVALENT 1
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIVEUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTORATIVE THERAPIES INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XFT MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMARTMISSIMO TECHNOLOGIES PTE LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Temperature Problem 4
Adverse Event Without Identified Device or Use Problem 4
Intermittent Energy Output 4
Charred 3
Energy Output Problem 2
Unintended Electrical Shock 2
Use of Device Problem 1
Power Conditioning Problem 1
Insufficient Information 1
Connection Problem 1
Total Device Problems 23


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