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510(k) Data Aggregation

    K Number
    K183215
    Device Name
    Focus TENS Therapy, Model PM710-M/-L
    Manufacturer
    Omron Healthcare, Inc.
    Date Cleared
    2019-09-07

    (292 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K152954,K180956
    Why did this record match?
    Device Name :

    Focus TENS Therapy, Model PM710-M/-L

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

    The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

    Device Description

    The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee. The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for the Omron Focus TENS Therapy, Model PM710-M/-L, based on the provided FDA 510(k) submission.

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not present a formal table of "acceptance criteria" against which a clinical study's performance metrics are directly compared. Instead, it demonstrates substantial equivalence through extensive non-clinical testing and comparison of technological characteristics with predicate and reference devices. The "performance data" provided refers exclusively to these non-clinical tests.

    However, based on the comparison tables, we can infer some "performance criteria" that the device implicitly meets by matching or being within acceptable ranges of the predicate and reference devices.

    Feature/ParameterAcceptance Criteria (Inferred from Predicate/Reference)Reported Device Performance (Omron Focus TENS PM710-M/-L)
    Classification Regulation21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief
    Product CodeNUH and NYN (Transcutaneous electrical nerve stimulator for pain relief)Primary: NUH, Secondary: NYN
    Indications for UseRelief of pain associated with sore or aching muscles (lower back, arms, legs, shoulders, or feet) due to strain from exercise or normal household work activities; symptomatic relief and management of chronic, intractable pain, and relief of pain associated with arthritis. The Quell reference device also includes temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities, and symptomatic relief and management of chronic intractable pain.Intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. Also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. (Narrower than Avail but similar to Quell for lower extremities and chronic pain/arthritis).
    Environments of UseClinics, hospital, and home environments (for predicate Avail and implied for other TENS devices)Clinics, hospital, and home environments
    Patient PopulationAdultAdult
    ContraindicationsAvoid use with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.Same as predicate and reference devices regarding cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
    Electrical ParametersOutput parameters within the range of predicate Avail device, and within IEC60601-2-10:2012 (Clause 201.4.2) limit of
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