510(k) Report

Devices descending from K181497

6 later devices reach HPM-6000UF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262353BTL-299-FBTL Industries, Inc.20260—
+1K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+1K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+1K241516BTL-398BTL Industries, Inc.20250—
+1K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+1K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—