Atlas FDA

KPI

96 FDA 510(k) clearances · Product code

152 daysmedian time to decision
304 days90th percentile
96clearances measured

FDA profile

Official device name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5320
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
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RecordFirmDate
Pelvic Muscle Trainer (KM510, KM516B) (K260178)Shenzhen Konmed Technology Co., Ltd.2026-06-18
Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) (K252601)Hunan Accurate Bio-Medical Technology Co., Ltd.2026-05-14
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (K252552)Shenzhen Changkun Technology Co., Ltd.2026-05-06
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) (K252831)Dolanvy (Suzhou) Medical Technology Co., Ltd.2026-04-28
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) (K252334)Pontemedag2026-04-17
Well-Life Incontinence Stimulation System (WL-2405i(P)) (K251760)Well-Life Healthcare , Ltd.2026-02-12
Regenesis EMS Chair (K251026)Trinity Medical Solutions2025-08-29
NeuroTrac® MyoPlus Pro (MYO120U) (K243079)Verity Medical , Ltd.2025-06-26
Levina Pelvic Floor Muscle Stimulator (RS-48) (K241862)Zmi Electronics , Ltd.2025-03-27
BTL-398 (K241516)BTL Industries, Inc.2025-02-10
Pelvic Floor Stimulator (Intrelief PFE) (K241899)Easymed Instruments Co., Ltd.2024-11-27
StarFormer (K234061)Fotona D.O.O.2024-07-01
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) (K233576)Shenzhen Konmed Technology Co., Ltd.2024-02-23
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes (K231166)Zmi Electronics , Ltd.2024-01-18
Unicare (K-UNICARE-USA) (K230983)Tenscare, Ltd.2023-10-20
MFG-05 (K230780)Zimmer Medizinsysteme GmbH2023-10-05
Pelvic Floor Muscle Stimulator (K230767)Nanjing Vishee Medical Technology Co., Ltd.2023-09-21
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode (K222528)Well-Life Healthcare Limited2022-12-29
Biofeedback Nerve and Muscle Stimulator (K220161)Shenzhen Konmed Technology Co., Ltd.2022-07-20
Keffort (MC-100, MC-100A) (K213133)Oriental Inspiration Limited2022-04-13
Everyway Incontinence Stimulation System (K213116)Everyway Medical Instruments Co.,Ltd2021-12-03
Incontinence Probe (K210441)Shenzhen Med-Link Electronics Tech Co., Ltd.2021-09-17
MyOnyx System (K201014)Thought Technology , Ltd.2021-01-13
InMode System with vTone Applicator (K200293)InMode , Ltd.2020-05-05
Perfect PFE (K191312)Tenscare, Ltd.2019-11-01
ApexMV (K182022)Incontrol Medical, LLC2019-03-15
HPM-6000UF (K181497)BTL Industries, Inc.2018-11-14
Incontinence Treatment Device, Model LT2061 (K171430)Shenzhen Dongdixin Technology Co., Ltd.2018-03-15
Pelvifine Pelvic Muscle Trainer (K163288)Shenzhen Konmed Technology Co., Ltd.2018-01-18
Everyway Incontinence Stimulation System (K161349)Everyway Medical Instrument Co., Ltd.2017-07-07
HPM-6000U (K162010)BTL Industries, Inc.2016-12-13
Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 (K161055)Fuji Dynamics , Ltd.2016-07-12
Yarlap II (K160773)International Trade Group, Inc.2016-05-04
Urinary Incontinence System (K142369)Guangzhou Finecure Medical Equipment Co.,Ltd2015-06-17
YARLAP (K141643)International Trade Group, Inc.2015-04-24
TensCare KegelFit (K142506)Tenscare, Ltd.2015-04-20
ApexM (K150183)Incontrol Medical, LLC2015-04-09
InTone (K150180)Incontrol Medical, LLC2015-03-16
ELECTRODE FOR URINARY INCONTINENCE (K140265)Guangzhou Finecure Medical Equipment Co.,Ltd2015-01-23
APEX (K141158)Incontrol Medical, LLC2014-11-26
INTONEMV (K134020)Incontrol Medical, LLC2014-02-25
INTONEMV (K133826)Incontrol Medical, LLC2014-01-06
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE (K122194)Everyway Medical Instruments Co.,Ltd2013-04-04
INWAVE (K121820)Zynex Medical, Inc.2012-08-24
INCONTROL (K110179)Incontrol Medical, LLC2012-02-22
TENSCARE ITOUCH SURE MODEL ITS (K103698)Tenscare, Ltd.2011-06-21
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM (K093600)Accelerated Care Plus2009-12-04
NUTRAC PELVATOR, MODEL PEL 200 (K083704)Verity Scientific , Ltd.2009-07-14
KEGEL8 PELVIC EXERCISER, MODEL OPH 400 (K081480)Ne Services , Ltd.2008-09-12
UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES (K070331)Laborie Medical Technologies2007-05-04
MYOTRAC INFINITI ELECTRICAL STIMULATOR (K053434)Thought Technology , Ltd.2006-03-15
SKYLARK URO PROBE (K053007)Skylark Device & Systems Co., Ltd.2005-12-05
EVADRI BLADDER CONTROL SYSTEMS (K050483)Hollister, Inc.2005-04-12
ATHENA PELVIC MUSCLE TRAINER II (K033256)Athena Feminine Technologies, Inc.2003-12-30
ELPHA 4 CONTI (K032988)Danmeter A/S2003-12-03
PATHWAY STM-10 PELVIC FLOOR STIMULATOR (K030039)The Prometheus Group2003-05-23
ATHENA PELVIC MUSCLE TRAINER (K023905)Athena Feminine Technologies, Inc.2003-04-30
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM (K023906)The Prometheus Group2003-02-19
MICROGYN PLUS STIMULATION DEVICE (K013141)Hollister, Inc.2001-12-19
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM (K011435)Hmt, Inc.2001-06-22
K.E.A.T. (K002154)Emd Electronic Medical Devices, Corp.2001-03-22
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM (K001903)Neotonus, Inc.2000-08-29
DETRUSAN 500 (K994109)Innovamed USA, Inc.2000-08-03
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 (K001515)The Prometheus Group2000-07-31
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR (K993976)The Prometheus Group2000-02-22
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES (K993721)Laborie Medical Tech Corp.1999-11-29
UROSTYM BIOFEEDBACK AND STIMULATION PROBES (K990041)Laborie Medical Tech Corp.1999-08-05
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP (K990456)Hollister, Inc.1999-03-25
SMALL VAGINAL/RECTAL ELECTRODE (K983206)Empi1998-11-03
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM (K973096)Neotonus, Inc.1998-06-12
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER (K974048)Hollister, Inc.1997-12-23
ELPHA 2000 CONTI (K964738)Dan Med, Inc.1997-08-14
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE (K972054)Empi1997-08-14
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM (K971527)Empi1997-06-30
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON (K971541)Hollister, Inc.1997-06-25
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (K970077)Utah Medical Products, Inc.1997-05-23
UROSTYM (K962009)Laborie Medical Technologies, Ltd.1997-05-20
MINNOVA PELVIC FLOOR STIMULATION SYSTEM (K970307)Empi1997-04-22
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL (K970602)Hollister, Inc.1997-04-15
LIBERTY RECTAL PELVIC FLOOR EXERCISER (K964526)Utah Medical Products, Inc.1997-02-10
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) (K964577)Empi1997-01-24
MICROGYN PLUS STIMULATION DEVICE (K963222)Hollister, Inc.1996-10-23
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER (K961872)Hollister, Inc.1996-08-09
LIBERTY LITE PFS SYSTEM (K960496)Utah Medical Products, Inc.1996-06-27
INNOVA RECTAL STIMULATON ELECTRODE (K954272)Empi1996-04-15
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC (K930530)Hollister, Inc.1995-10-17
TS-700P CONTROL XP ELECTRICAL STIMULATOR (K945292)Myo/Kinetic Systems, Inc.1995-04-12
LIBERTY (K943250)Utah Medical Products, Inc.1995-02-09
INNOVA PELVIC FLOOR STIMULATION SYSTEM (K941911)Empi1995-01-20
STIMTECH PFX, CATALOG NUMBER 78-8540 (K922562)Stimtech Products1993-10-13
TBD (K910081)Empi1991-07-15
NONIMPLANTED ELECTRICAL CONTINENCE DEVICE (K891007)Tridak Division of Indicon, Inc.1990-06-07
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI (K891773)Hollister, Inc.1989-08-23
CATR(TM)-H CARDIOTOMY HOLDER (K874867)Bentley Laboratories, Inc.1988-02-02
}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR (K850167)Urologics, Inc.1985-04-09
RADIOISOTOPE CALIBRATOR (CRCO-22NB) (K761145)G.D. Searle and Co.1976-12-16

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