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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bath, paraffin
Regulation Description Paraffin bath.
Product CodeIMC
Regulation Number 890.5110
Device Class 2


Premarket Reviews
ManufacturerDecision
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
HOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Malfunction 3
Use of Device Issue 2
Burn hole(s) 1
Component(s), overheating of 1
Leak 1
Total Device Problems 8

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