510(k) Report

Devices descending from K973096

9 later devices reach Neotonus Model 1000 Muscle Stimulator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234061StarFormerFotona D.O.O.20240—
+1K162010HPM-6000UBTL Industries, Inc.20167—
+2K181497HPM-6000UFBTL Industries, Inc.20186—
+3K262353BTL-299-FBTL Industries, Inc.20260—
+3K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+3K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+3K241516BTL-398BTL Industries, Inc.20250—
+3K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+3K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—