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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stationary ultrasonic diathermy device for use in applying therapeutic deep heat
Regulation Description Ultrasonic diathermy.
Definition Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Product CodePFW
Regulation Number 890.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
NANOVIBRONIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZETROZ SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2026 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Blood Loss/Bleeding 1 1
Pain 1 1
Swelling/ Edema 1 1

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