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510(k) Data Aggregation

    K Number
    K200694
    Device Name
    Perfect EMS
    Manufacturer
    TensCare Ltd.
    Date Cleared
    2021-06-04

    (444 days)

    Product Code
    NUH, NGX
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TensCare Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, pushbutton controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available. Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050) Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)
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    K Number
    K191312
    Device Name
    Perfect PFE
    Manufacturer
    TensCare Ltd.
    Date Cleared
    2019-11-01

    (170 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    TensCare Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Perfect 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
    The Perfect PFE is a hand-held, home-use device designed to treat stress, urge and mixed urinary continence in women and maintain urinary continence in women. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe. The probe connects to the control unit by cable and plug and is inserted into the end user. The probe has a recommended usage duration of 6 months. The device is battery powered, single channel, home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient. It has four preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors. Accessories: Lead Wire (L-CPT) Liberty Loop vaginal probe (X-VPL)
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    K Number
    K142506
    Device Name
    TensCare KegelFit
    Manufacturer
    TENSCARE LTD.
    Date Cleared
    2015-04-20

    (224 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    TENSCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support. The KegelFit is intended for OTC sale.
    Device Description
    The KegelFit is a hand-held, home-use device designed to treat female stress urinary incontinence. The device is supplied with a vaginal two electrode stimulation probe (Trainer). The trainer connects to the control unit by cable and plug and is inserted into the vagina by the end user. Electrical stimulation is delivered via stainless steel electrodes on the trainer to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The device is battery powered single channel home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has two preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.
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    K Number
    K103698
    Device Name
    TENSCARE ITOUCH SURE MODEL ITS
    Manufacturer
    TENSCARE LTD.
    Date Cleared
    2011-06-21

    (183 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    TENSCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The itouch Sure 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
    Device Description
    The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has four preset treatment programs, an adjustable treatment timer, a compliance monitor, and open circuit detectors.
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    K Number
    K023997
    Device Name
    TENSCARE ULTIMA NMS/EMS
    Manufacturer
    TENSCARE LTD.
    Date Cleared
    2003-03-03

    (90 days)

    Product Code
    IPF, GZJ
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TENSCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the TENS function: TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute pain. For the EMS function: The Ultima NMS/EMS is indicated for: Relaxation of muscle spasm. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Prevention of venous thrombosis of the calf. muscles immediately after surgery. Maintaining or increasing range of motion.
    Device Description
    For the TENS function: A portable TENS device for pain relief. For the EMS function: A portable EMS device for the re-education of muscles. The Ultima NMS/EMS (the "New Device") brings together TENS and Powered Muscle Stimulator functions from two previously cleared for market devices; namely the Ultima TENS (K020846) for the TENS functions and the TensCare XL-Y3 (K011543) for the Powered Muscle Stimulator functions. The electrical. EMC and software technologies used in the Ultima NMS/EMS (the 'New Device'), are identical to the Ultima TENS (the Predicate device - (K020846), in that the same CPU series is utilised (the difference being that the variant used has increased memory capacity). In addition, the "New Device" uses the same passive and active electrical components and PCB layout, as the Predicate devices. The Powered Muscle Stimulator functions are derived from software programmed into the CPU device and are based on and virtually identical to the Predicate device. The TensCare Ultima NMS/EMS has a Doctor Important anti-Misuse feature: Lock facility, which means that at the Treating Physician's discretion, the patient has no control over the devices outputs; the Programs are pre-set by the Treating Physician. The use of 'shrouded patient cable connectors' to comply with FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables" is utilised to further ensure no hazards exist.
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