510(k) Report

Devices descending from K191568

6 later devices reach sam 2.0 Long Duration Ultrasound System through their predicates, nearest generation first.

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