510(k) Report

Devices descending from K080950

34 later devices reach Stiwell MED4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—
+1K232786Stimulation System (PA series, PR series, S series and Q series)Edan Instruments, Inc.20240—
+1K230701Stim2GoPAJUNK GmbH Medizintechnologie20230—
+1K210002Stella BioEgzotech Sp. Z O. O.20211—
+1K202648Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20202—
+1K200088g.Estim FESG.Tec Medical Engineering GmbH20200—
+1K201290Medline DeNovo 4Pro Electrical Stimulation DeviceMedline Industries, Inc.20202—
+1K110179IncontrolIncontrol Medical, LLC201221—
+2K243079NeuroTrac® MyoPlus Pro (MYO120U)Verity Medical, Ltd.20250—
+2K241488TrainFES AdvanceTrainfes20250—
+2K222201Biological Feedback and Stimulation SystemMedlander Medical Technology, Inc.20220—
+2K220161Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20220—
+2K213043Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd.20220—
+2K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+2K142369Urinary Incontinence SystemGuangzhou Finecure Medical Equipment Co.,Ltd20150—
+2K150183ApexMIncontrol Medical, LLC20153—
+2K150180InToneIncontrol Medical, LLC20150—
+2K141158APEXIncontrol Medical, LLC20149—
+2K134020IntonemvIncontrol Medical, LLC201410—
+2K133826IntonemvIncontrol Medical, LLC20140—
+3K182022ApexMVIncontrol Medical, LLC20191—
+3K181497HPM-6000UFBTL Industries, Inc.20186—
+3K142506TensCare KegelFitTenscare, Ltd.20154—
+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—
+4K241516BTL-398BTL Industries, Inc.20250—
+4K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+4K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+4K191312Perfect PFETenscare, Ltd.20193—
+5K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+5K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+5K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—