510(k) Report

Devices descending from K162010

7 later devices reach HPM-6000U through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181497HPM-6000UFBTL Industries, Inc.20186—
+2K262353BTL-299-FBTL Industries, Inc.20260—
+2K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+2K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+2K241516BTL-398BTL Industries, Inc.20250—
+2K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+2K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—