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510(k) Data Aggregation

    K Number
    K140467
    Device Name
    FLEX-MT +
    Manufacturer
    EMSI
    Date Cleared
    2014-10-07

    (225 days)

    Product Code
    IPF,GZJ
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine (PM)
    Reference & Predicate Devices
    K083030,K021100
    Why did this record match?
    Reference Devices :

    K083030, K021100

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    As prescribed by a physician for the following:

    TENS- Transcutaneous Nerve Stimulation

    • Symptomatic relief of chronic intractable pain .
    • . Post traumatic and post surgical pain relief

    EMS- Electrical Muscle Stimulation

    • . Relaxation of muscle spasm
    • . Increasing local blood circulation
    • . Muscle re-education
    • . Prevention or retardation of disuse atrophy
    • Prevention of venous thrombosis of the calf muscles immediately after surgery
    • . Maintaining or increase range of motion
    Device Description

    The Flex-MT + is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 700 mAh 4.8V Ni MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

    AI/ML Overview

    The provided text is a 510(k) summary for the Flex-MT+ device. It outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence.

    Here's an analysis of the acceptance criteria and the "study" (in this case, performance testing) that proves the device meets them, based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" for performance, but rather demonstrates substantial equivalence by comparing the Flex-MT+ device's technical characteristics and performance to two predicate devices (K083030 EMSI TENS-EMS-14 (Flex MT) and K021100 EMPI 300 PV). The "Comment" column in the provided tables effectively acts as the "acceptance criteria" by stating whether the subject device's performance is comparable to or within acceptable limits of the predicate devices and relevant standards.

    Acceptance Criteria (Derived) and Reported Device Performance (Flex-MT+)

    CharacteristicAcceptance Criteria (Derived from Predicates & Standards)Reported Device Performance (Flex-MT+)Fulfilled?
    Indications for UseSame as predicate TENS and NMES modes.Same as K083030 EMSI TENS-EMS-14 (Flex MT) and K021100 EMPI 300 PVYes
    Power SourceBattery operated; battery charger available (consistent with EMPI predicate).700 mAh 4.8V Ni-MH, rechargeable battery pack and chargerYes
    Patient Leakage Current
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