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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
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 4
  1.  K191568  sam 2.0 Long Duration Ultrasound System
  2.  K211513  sam X1 Long Duration Ultrasound Device
  3.  K223019  sam 2.0 Long Ultrasound Device
  4.  K233210  sam CS Long Duration Ultrasound Device

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