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510(k) Data Aggregation

    K Number
    K233461
    Device Name
    Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
    Manufacturer
    Hi-Dow International, Inc.
    Date Cleared
    2024-01-19

    (88 days)

    Product Code
    NUH,NGX
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

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

    TENS: To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: Intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device, a regulatory document. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given context.

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