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510(k) Data Aggregation

    K Number
    K241862
    Device Name
    Levina Pelvic Floor Muscle Stimulator (RS-48)
    Manufacturer
    ZMI Electronics Ltd.
    Date Cleared
    2025-03-27

    (273 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
    Device Description
    Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women. The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.
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    K Number
    K241516
    Device Name
    BTL-398
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2025-02-10

    (257 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
    Device Description
    The BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only. The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments. The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.
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    K Number
    K241899
    Device Name
    Pelvic Floor Stimulator (Intrelief PFE)
    Manufacturer
    EasyMed Instruments Co., Ltd.
    Date Cleared
    2024-11-27

    (152 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
    Device Description
    Not Found
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    K Number
    K234061
    Device Name
    StarFormer
    Manufacturer
    Fotona d.o.o.
    Date Cleared
    2024-07-01

    (192 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
    Device Description
    StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the seat of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current which causes muscle contraction in the entire pelvic floor area, increasing the strength and endurance of the pelvic floor. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and a chair.
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    K Number
    K233576
    Device Name
    Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
    Manufacturer
    Shenzhen Konmed Technology Co., Ltd.
    Date Cleared
    2024-02-23

    (108 days)

    Product Code
    KPI, HIR
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konmed Incontinence Stimulation Electrode include Vaginal Probe KM-504, KM-505, KM-506, KM-507, KM-5013 & Rectal Probe KM-502. KM-5018 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
    Device Description
    Not Found
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    K Number
    K231166
    Device Name
    Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
    Manufacturer
    ZMI Electronics Ltd.
    Date Cleared
    2024-01-18

    (268 days)

    Product Code
    KPI, HIR
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
    Device Description
    Levina Incontinence Stimulation Electrodes are used to treat incontinence when paired with compatible, FDA-cleared electrical stimulators. The probes are intended to provide electrical stimulation to pelvic musculature and for the purpose of rehabilitation of pelvic floor muscles and restoration of neuromuscular control during treatment. The probes come in different models and are available for both vaginal and rectal insertion. The probes are used directly by the patients for home care and are for single-patient, repeat-use. The device comes non-sterile and should be cleaned before and after each use with water and mild soap or neutral detergent.
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    K Number
    K230983
    Device Name
    Unicare (K-UNICARE-USA)
    Manufacturer
    TensCare Ltd
    Date Cleared
    2023-10-20

    (197 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
    Device Description
    Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.
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    K Number
    K230780
    Device Name
    MFG-05
    Manufacturer
    Zimmer MedizinSysteme GmbH
    Date Cleared
    2023-10-05

    (197 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
    Device Description
    The MFG-05 is a non-invasive therapeutic device produces a magnetic field that interacts with the tissues of the human body. By stimulation of the pelvic floor musculature, the MFG-05 helps to treat of male and female urinary incontinence. The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. One applicator is available for therapy and is positioned centrally under the pelvic floor of the patient while the patient is wearing sport pants or any other pants without metallic parts. The device is for prescription use and used by a trained medical professional in a professional healthcare facility. The main body of MFG-05 is used to control the function of magnetic stimulation. It is operated with parameters such as frequency, time and intensity. These parameters can be controlled by the user on screen display and with the help of a rotary knob at the user control panel.
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    K Number
    K230767
    Device Name
    Pelvic Floor Muscle Stimulator
    Manufacturer
    Nanjing Vishee Medical Technology Co., Ltd.
    Date Cleared
    2023-09-21

    (185 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
    Device Description
    The Pelvic Floor Muscle Stimulator (model: MagBelle AF180) is a non-invasive therapeutic device which produces electromagnetic field that interacts with the tissues in the pelvic region of the human body. The electromagnetic field delivered in the muscular tissue area triggers the muscle stimulation. MagBelle AF180 consists of the main unit and the chair applicator. The MagBelle AF180 is equipped with a color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters can also be set using the touch screen, buttons and knob on the device. During the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The subject device should only be used under the continued supervision or licensed practitioner. The device supports 3 different function modes: Magnetic stimulation function, Kegel biofeedback training function and Triggering magnetic stimulation function of Magnetic stimulation function and Kegel biofeedback training function).
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    K Number
    K222528
    Device Name
    Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
    Manufacturer
    Well-Life Healthcare Limited
    Date Cleared
    2022-12-29

    (129 days)

    Product Code
    KPI, HIR
    Regulation Number
    876.5320
    Why did this record match?
    Product Code :

    KPI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
    Device Description
    Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence. Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual. Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).
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