510(k) Report

Devices descending from K001515

50 later devices reach Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083679Uroval BRS System, Model BRS01; Telesis, Model PROMO1Uroval20090—
+1K050483Evadri Bladder Control SystemsHollister, Inc.200537—
+1K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc.200314—
+1K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group200339—
+2K134020IntonemvIncontrol Medical, LLC201410—
+2K110179IncontrolIncontrol Medical, LLC201221—
+2K053434Myotrac Infiniti Electrical StimulatorThought Technology, Ltd.200636—
+2K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc.200313—
+2K030039Pathway STM-10 Pelvic Floor StimulatorThe Prometheus Group20030—
+3K201014MyOnyx SystemThought Technology, Ltd.20211—
+3K201290Medline DeNovo 4Pro Electrical Stimulation DeviceMedline Industries, Inc.20202—
+3K182022ApexMVIncontrol Medical, LLC20191—
+3K181497HPM-6000UFBTL Industries, Inc.20186—
+3K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+3K142369Urinary Incontinence SystemGuangzhou Finecure Medical Equipment Co.,Ltd20150—
+3K150183ApexMIncontrol Medical, LLC20153—
+3K150180InToneIncontrol Medical, LLC20150—
+3K141158APEXIncontrol Medical, LLC20149—
+3K133826IntonemvIncontrol Medical, LLC20140—
+3K080950Stiwell MED4Otto Bock, Austria GmbH200934—
+3K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd.200812—
+4K262353BTL-299-FBTL Industries, Inc.20260—
+4K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+4K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+4K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+4K243079NeuroTrac® MyoPlus Pro (MYO120U)Verity Medical, Ltd.20250—
+4K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—
+4K241862Levina Pelvic Floor Muscle Stimulator (RS-48)Zmi Electronics, Ltd.20250—
+4K241516BTL-398BTL Industries, Inc.20250—
+4K232786Stimulation System (PA series, PR series, S series and Q series)Edan Instruments, Inc.20240—
+4K230701Stim2GoPAJUNK GmbH Medizintechnologie20230—
+4K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+4K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+4K213043Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd.20220—
+4K210002Stella BioEgzotech Sp. Z O. O.20211—
+4K202648Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20202—
+4K200088g.Estim FESG.Tec Medical Engineering GmbH20200—
+4K200293InMode System with vTone ApplicatorInMode, Ltd.20200—
+4K141643YarlapInternational Trade Group, Inc.201510—
+4K142506TensCare KegelFitTenscare, Ltd.20154—
+5K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.20260—
+5K241488TrainFES AdvanceTrainfes20250—
+5K222201Biological Feedback and Stimulation SystemMedlander Medical Technology, Inc.20220—
+5K220161Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20220—
+5K191312Perfect PFETenscare, Ltd.20193—
+5K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd.20170—
+5K160773Yarlap IIInternational Trade Group, Inc.20162—
+6K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+6K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+6K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—