510(k) Report

Devices descending from K930530

67 later devices reach Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013612Incare Pelvic Floor Therapy SystemHollister, Inc.200238—
+1K993976Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorThe Prometheus Group20000—
+1K993411Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model FS-HMTRMega Electronics, Ltd.20000—
+1K990456Anal 2 Electrode Stimulation/Emg Probe - W/StopHollister, Inc.19996—
+1K971541Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc.19976—
+1K963222Microgyn Plus Stimulation DeviceHollister, Inc.199626—
+1K961872Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc.199646—
+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—
+2K050483Evadri Bladder Control SystemsHollister, Inc.200537—
+2K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc.200314—
+2K013141Microgyn Plus Stimulation DeviceHollister, Inc.20010—
+2K973096Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc.19989—
+2K974048Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc.199742—
+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—
+3K134020IntonemvIncontrol Medical, LLC201410—
+3K110179IncontrolIncontrol Medical, LLC201221—
+3K053434Myotrac Infiniti Electrical StimulatorThought Technology, Ltd.200636—
+3K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc.200313—
+3K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group200339—
+4K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe…Zmi Electronics, Ltd.20240—
+4K201014MyOnyx SystemThought Technology, Ltd.20211—
+4K201290Medline DeNovo 4Pro Electrical Stimulation DeviceMedline Industries, Inc.20202—
+4K182022ApexMVIncontrol Medical, LLC20191—
+4K181497HPM-6000UFBTL Industries, Inc.20186—
+4K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+4K142369Urinary Incontinence SystemGuangzhou Finecure Medical Equipment Co.,Ltd20150—
+4K150183ApexMIncontrol Medical, LLC20153—
+4K150180InToneIncontrol Medical, LLC20150—
+4K141158APEXIncontrol Medical, LLC20149—
+4K133826IntonemvIncontrol Medical, LLC20140—
+4K080950Stiwell MED4Otto Bock, Austria GmbH200934—
+4K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd.200812—
+4K030039Pathway STM-10 Pelvic Floor StimulatorThe Prometheus Group20030—
+5K262353BTL-299-FBTL Industries, Inc.20260—
+5K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+5K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+5K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+5K243079NeuroTrac® MyoPlus Pro (MYO120U)Verity Medical, Ltd.20250—
+5K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—
+5K241862Levina Pelvic Floor Muscle Stimulator (RS-48)Zmi Electronics, Ltd.20250—
+5K241516BTL-398BTL Industries, Inc.20250—
+5K232786Stimulation System (PA series, PR series, S series and Q series)Edan Instruments, Inc.20240—
+5K230701Stim2GoPAJUNK GmbH Medizintechnologie20230—
+5K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+5K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+5K213043Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd.20220—
+5K210002Stella BioEgzotech Sp. Z O. O.20211—
+5K202648Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20202—
+5K200088g.Estim FESG.Tec Medical Engineering GmbH20200—
+5K200293InMode System with vTone ApplicatorInMode, Ltd.20200—
+5K141643YarlapInternational Trade Group, Inc.201510—
+5K142506TensCare KegelFitTenscare, Ltd.20154—
+6K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.20260—
+6K241488TrainFES AdvanceTrainfes20250—
+6K222201Biological Feedback and Stimulation SystemMedlander Medical Technology, Inc.20220—
+6K220161Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20220—
+6K191312Perfect PFETenscare, Ltd.20193—
+6K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd.20170—
+6K160773Yarlap IIInternational Trade Group, Inc.20162—
+7K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+7K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+7K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—