510(k) Report

Devices descending from K960496

30 later devices reach Liberty Lite PFS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc.200313—
+1K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc.200314—
+1K973096Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc.19989—
+1K970077Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044)Utah Medical Products, Inc.19970—
+1K970307Minnova Pelvic Floor Stimulation SystemEmpi199712—
+1K964526Liberty Rectal Pelvic Floor ExerciserUtah Medical Products, Inc.19970—
+2K234061StarFormerFotona D.O.O.20240—
+2K162010HPM-6000UBTL Industries, Inc.20167—
+2K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd.200812—
+2K972054Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable ElectrodeEmpi19970—
+2K971527Innosense Pelvic Floor Stimulation and Electromyography SystemEmpi19970—
+3K241862Levina Pelvic Floor Muscle Stimulator (RS-48)Zmi Electronics, Ltd.20250—
+3K200293InMode System with vTone ApplicatorInMode, Ltd.20200—
+3K181497HPM-6000UFBTL Industries, Inc.20186—
+3K141643YarlapInternational Trade Group, Inc.201510—
+4K262353BTL-299-FBTL Industries, Inc.20260—
+4K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.20260—
+4K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+4K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+4K241516BTL-398BTL Industries, Inc.20250—
+4K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+4K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+4K191312Perfect PFETenscare, Ltd.20193—
+4K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+4K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd.20170—
+4K160773Yarlap IIInternational Trade Group, Inc.20162—
+5K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+5K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+5K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+5K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—