• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device wound cleaner, ultrasound
Regulation Description Low energy ultrasound wound cleaner.
Definition The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound
Product CodeNRB
Regulation Number 878.4410
Device Class 2


Premarket Reviews
ManufacturerDecision
AROBELLA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
CELLERATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 2

-
-