Product code KPI— Gastroenterology, Urology
Everyway Incontinence Stimulation System
- Classification name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 96
- First cleared
- Most recent
Market context for product code KPI
FDA has cleared devices under product code KPI between 1976 and 2026, filed by 52 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code KPI
Recent clearances under product code KPI
- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K252601 — Pelvic Muscle Trainer (4 models)
- K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
- K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P))
- K251026 — Regenesis EMS Chair
- K243079 — NeuroTrac® MyoPlus Pro (MYO120U)
- K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48)
- K241516 — BTL-398
- K241899 — Pelvic Floor Stimulator (Intrelief PFE)
- K234061 — StarFormer
- K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013 +1 more
- K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
- K230983 — Unicare (K-UNICARE-USA)
- K230780 — MFG-05
- K230767 — Pelvic Floor Muscle Stimulator
- K222528 — Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
- K220161 — Biofeedback Nerve and Muscle Stimulator
- K213133 — Keffort (MC-100, MC-100A)
- K213116 — Everyway Incontinence Stimulation System
- K210441 — Incontinence Probe
- K201014 — MyOnyx System
- K200293 — InMode System with vTone Applicator
- K191312 — Perfect PFE
- K182022 — ApexMV
- K181497 — HPM-6000UF
- K171430 — Incontinence Treatment Device, Model LT2061
- K163288 — Pelvifine Pelvic Muscle Trainer
- K161349 — Everyway Incontinence Stimulation System
- K162010 — HPM-6000U
- K161055 — Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
- K160773 — Yarlap II
- K142369 — Urinary Incontinence System
- K141643 — YARLAP
- K142506 — TensCare KegelFit
- K150183 — ApexM
- K150180 — InTone
- K140265 — ELECTRODE FOR URINARY INCONTINENCE
- K141158 — APEX
- K134020 — INTONEMV
- K133826 — INTONEMV
- K122194 — LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
- K121820 — INWAVE
- K110179 — INCONTROL
- K103698 — TENSCARE ITOUCH SURE MODEL ITS
- K093600 — OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
- K083704 — NUTRAC PELVATOR, MODEL PEL 200
- K081480 — KEGEL8 PELVIC EXERCISER, MODEL OPH 400
- K070331 — UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
- K053434 — MYOTRAC INFINITI ELECTRICAL STIMULATOR
- K053007 — SKYLARK URO PROBE
- K050483 — EVADRI BLADDER CONTROL SYSTEMS
- K033256 — ATHENA PELVIC MUSCLE TRAINER II
- K032988 — ELPHA 4 CONTI
- K030039 — PATHWAY STM-10 PELVIC FLOOR STIMULATOR
- K023905 — ATHENA PELVIC MUSCLE TRAINER
- K023906 — PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
- K013141 — MICROGYN PLUS STIMULATION DEVICE
- K011435 — HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
- K002154 — K.E.A.T.
- K001903 — NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
- K994109 — DETRUSAN 500
- K001515 — PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
- K993976 — PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
- K993721 — UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
- K990041 — UROSTYM BIOFEEDBACK AND STIMULATION PROBES
- K990456 — ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
- K983206 — SMALL VAGINAL/RECTAL ELECTRODE
- K973096 — NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
- K974048 — INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
- K964738 — ELPHA 2000 CONTI
- K972054 — INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
- K971527 — INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
- K971541 — VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
- K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
- K962009 — UROSTYM
- K970307 — MINNOVA PELVIC FLOOR STIMULATION SYSTEM
- K970602 — VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
- K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER
- K964577 — INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)
- K963222 — MICROGYN PLUS STIMULATION DEVICE
- K961872 — INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
- K960496 — LIBERTY LITE PFS SYSTEM
- K954272 — INNOVA RECTAL STIMULATON ELECTRODE
- K930530 — INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
- K945292 — TS-700P CONTROL XP ELECTRICAL STIMULATOR
- K943250 — LIBERTY
- K941911 — INNOVA PELVIC FLOOR STIMULATION SYSTEM
- K922562 — STIMTECH PFX, CATALOG NUMBER 78-8540
- K910081 — TBD
- K891007 — NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
- K891773 — MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI
- K874867 — CATR(TM)-H CARDIOTOMY HOLDER
- K850167 — }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR
- K761145 — RADIOISOTOPE CALIBRATOR (CRCO-22NB)
Data sourced from openFDA. This site is unofficial and independent of the FDA.