510(k) Report

Devices descending from K120171

8 later devices reach Accusonic Advantage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130978ZTX Ultrasonic Diathermy DeviceZetroz, Inc.20137—
+2K191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC20206—
+3K240788Ultrasound StimulatorJkh Health Co., Ltd.20250—
+3K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC20231—
+3K222098ManaSport+Manamed, Inc.20231—
+3K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC20211—
+4K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC20260—
+4K233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC20230—