510(k) Report

Devices descending from K910081

35 later devices reach TBD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964577Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal…Empi19976—
+1K963222Microgyn Plus Stimulation DeviceHollister, Inc.199626—
+1K954272Innova Rectal Stimulaton ElectrodeEmpi19967—
+2K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc.200314—
+2K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc.20023—
+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—
+3K234061StarFormerFotona D.O.O.20240—
+3K162010HPM-6000UBTL Industries, Inc.20167—
+3K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc.200313—
+3K020952Surx RF SystemSurx, Inc.20021—
+3K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022—
+4K181497HPM-6000UFBTL Industries, Inc.20186—
+4K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd.200812—
+4K042132Novasys Transurethral RF SystemNovasys Medical, Inc.200401
+5K262353BTL-299-FBTL Industries, Inc.20260—
+5K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+5K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+5K241862Levina Pelvic Floor Muscle Stimulator (RS-48)Zmi Electronics, Ltd.20250—
+5K241516BTL-398BTL Industries, Inc.20250—
+5K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+5K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+5K200293InMode System with vTone ApplicatorInMode, Ltd.20200—
+5K141643YarlapInternational Trade Group, Inc.201510—
+6K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.20260—
+6K191312Perfect PFETenscare, Ltd.20193—
+6K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+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—
+7K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+7K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+7K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—