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510(k) Data Aggregation

    K Number
    K213913
    Device Name
    leva Pelvic Health System
    Manufacturer
    Renovia Inc.
    Date Cleared
    2022-06-30

    (197 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renovia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The leva Pelvic Health System is intended for: 1) Strengthening of the pelvic floor muscles; 2) Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women; 3) Rehabilitation and training of weak pelvic for the first-line treatment of chronic fecal incontinence (>3month uncontrolled passage of feces) in women. This device interacts with the user via smart phone technology.
    Device Description
    The leva Pelvic Health System ("leva PHS" or "leva System") is a prescription intra-vaginal device designed to allow the user to rehabilitate and strengthen their pelvic floor muscles ("PFM") as well as allow them to monitor their progress during pelvic floor muscle training ("PFMT"). The leva system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient's mobile device. The leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient.
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    K Number
    K212495
    Device Name
    Leva Pelvic Health System
    Manufacturer
    Renovia Inc.
    Date Cleared
    2021-09-08

    (30 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renovia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The leva Pelvic Health System is intended for: 1) Strengthening of the pelvic floor muscles; 2) Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women. This device interacts with the user via smart phone technology.
    Device Description
    The leva Pelvic Health System ("leva System") is a prescription intra-vaginal device designed to allow the user (or woman) to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The leva system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient's mobile device. The leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient. The leva PHS consists of a probe, storage case, associated batteries, and the Renovia Digital Health App (App). Thermoplastic elastomer (TPE) was used as the material overlay for the electronics and six accelerometers are contained within the probe. Additional electronics are contained in the storage case to transmit data wirelessly between the device and the App.
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    K Number
    K192270
    Device Name
    LEva Pelvic Digital Health System
    Manufacturer
    Renovia Inc.
    Date Cleared
    2019-11-22

    (92 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renovia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The leva Pelvic Digital Health System is intended for: 1) Strengthening of the pelvic floor muscles; 2) Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women. This device interacts with the user via smart phone technology
    Device Description
    The leva-02 PDHS is a prescription intra-vaginal device designed to allow the user (or woman) to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The leva-02 is designed to wirelessly facilitate pelvic floor muscle training (PFMT) in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded to the patient's mobile device. The levo-02 is designed to be used vaginally and is intended to be used repeatedly by a single patient. The leva-02 consists of a probe, storage case, associated batteries and the Renovia Digital Health App (App). Thermoplastic elastomer (TPE) was used as the material overlay for the electronics and six accelerometers are contained within the probe. Additional electronics are contained in the storage case to transmit data wirelessly between the device and the App.
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    K Number
    K180637
    Device Name
    leva Pelvic Floor Trainer
    Manufacturer
    Renovia Inc.
    Date Cleared
    2018-04-04

    (23 days)

    Product Code
    HIR, REV
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renovia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The leva Pelvic Digital Health System is intended for: 1) Strengthening of the pelvic floor muscles; 2) Rehabilitation and training of weak pelvic floor muscles for the treatment of stress. mixed and mild to moderate urgency urinary incontinence in women. This device interacts with the user via smart phone technology.
    Device Description
    The leva Pelvic Digital Health System (leva PDHS) is specifically designed to facilitate pelvic floor exercise training to strengthen pelvic floor muscles and for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women. The leva PDHS is intended to be used repeatedly by a single patient. The device is designed to be used vaginally. The hardware consists of the training device itself and an associated battery powered electronics box. The training device has a biocompatible, colored silicone covering which isolates the motion electronics from the environment. The leva PDHS uses an app to connect via smart phone. This enables the user to visualize the Kegel exercise she is being trained on.
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