510(k) Report

Devices descending from K891773

50 later devices reach Microgyn II Elec Stim Device Treat of Urin Inconti through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993976Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorThe Prometheus Group20000—
+1K990456Anal 2 Electrode Stimulation/Emg Probe - W/StopHollister, Inc.19996—
+1K971541Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc.19976—
+1K970307Minnova Pelvic Floor Stimulation SystemEmpi199712—
+1K970602Vaginal 2 Electrode Stimulation/Emg Probe-SmallHollister, Inc.19977—
+1K964526Liberty Rectal Pelvic Floor ExerciserUtah Medical Products, Inc.19970—
+1K963222Microgyn Plus Stimulation DeviceHollister, Inc.199626—
+1K960496Liberty Lite PFS SystemUtah Medical Products, Inc.199630—
+1K954272Innova Rectal Stimulaton ElectrodeEmpi19967—
+2K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/…Fuji Dynamics, Ltd.20161—
+2K122194Life-Care Vaginal Probe Life-Care Anal ProbeEveryway Medical Instruments Co.,Ltd20133—
+2K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc.200313—
+2K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc.200314—
+2K013141Microgyn Plus Stimulation DeviceHollister, Inc.20010—
+2K983206Small Vaginal/Rectal ElectrodeEmpi19980—
+2K973096Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc.19989—
+2K972054Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable ElectrodeEmpi19970—
+2K971527Innosense Pelvic Floor Stimulation and Electromyography SystemEmpi19970—
+2K970077Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044)Utah Medical Products, Inc.19970—
+2K964577Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal…Empi19976—
+3K234061StarFormerFotona D.O.O.20240—
+3K222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…Well-Life Healthcare Limited20221—
+3K210441Incontinence ProbeShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+3K162010HPM-6000UBTL Industries, Inc.20167—
+3K140265Electrode for Urinary IncontinenceGuangzhou Finecure Medical Equipment Co.,Ltd20150—
+3K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd.200812—
+3K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc.20023—
+4K241862Levina Pelvic Floor Muscle Stimulator (RS-48)Zmi Electronics, Ltd.20250—
+4K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe…Zmi Electronics, Ltd.20240—
+4K200293InMode System with vTone ApplicatorInMode, Ltd.20200—
+4K181497HPM-6000UFBTL Industries, Inc.20186—
+4K141643YarlapInternational Trade Group, Inc.201510—
+4K020952Surx RF SystemSurx, Inc.20021—
+4K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022—
+5K262353BTL-299-FBTL Industries, Inc.20260—
+5K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.20260—
+5K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+5K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+5K241516BTL-398BTL Industries, Inc.20250—
+5K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+5K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+5K191312Perfect PFETenscare, Ltd.20193—
+5K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+5K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd.20170—
+5K160773Yarlap IIInternational Trade Group, Inc.20162—
+5K042132Novasys Transurethral RF SystemNovasys Medical, Inc.200401
+6K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+6K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+6K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+6K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—