510(k) Report

Devices descending from K130978

7 later devices reach ZTX Ultrasonic Diathermy Device through their predicates, nearest generation first.

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