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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device diathermy, shortwave, for use in applying therapeutic deep heat
Regulation Description Shortwave diathermy.
Product CodeIMJ
Regulation Number 890.5290
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCELERATED CARE PLUS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fire 1
Loose or Intermittent Connection 1
Device Inoperable 1
Smoking 1
Total Device Problems 4

Recalls
Manufacturer Recall Class Date Posted
1 DJO, LLC II Oct-15-2015

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