510(k) Report

Devices descending from K941911

20 later devices reach Innova Pelvic Floor Stimulation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103698Tenscare Itouch Sure Model ItsTenscare, Ltd.20116—
+1K971527Innosense Pelvic Floor Stimulation and Electromyography SystemEmpi19970—
+1K970307Minnova Pelvic Floor Stimulation SystemEmpi199712—
+2K142369Urinary Incontinence SystemGuangzhou Finecure Medical Equipment Co.,Ltd20150—
+2K142506TensCare KegelFitTenscare, Ltd.20154—
+2K973096Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc.19989—
+2K972054Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable ElectrodeEmpi19970—
+3K234061StarFormerFotona D.O.O.20240—
+3K191312Perfect PFETenscare, Ltd.20193—
+3K162010HPM-6000UBTL Industries, Inc.20167—
+4K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+4K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+4K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—
+4K181497HPM-6000UFBTL Industries, Inc.20186—
+5K262353BTL-299-FBTL Industries, Inc.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—