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510(k) Data Aggregation

    K Number
    K170659
    Device Name
    IQ Technologies
    Manufacturer
    IQ Technologies Inc.
    Date Cleared
    2017-05-26

    (84 days)

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

    IQ Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. The double-channel subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The electrode pad used consists of gel, carbon film, cloth backing, and electrode connector, which is 510(k)-cleared and biocompatible, According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
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    K Number
    K131290
    Device Name
    IQ TECHNOLOGIES
    Manufacturer
    IQ TECHNOLOGIES INC.
    Date Cleared
    2014-08-06

    (457 days)

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

    IQ TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. The double-channel subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The electrode pad used consists of gel, carbon film, cloth backing, and electrode connector, which is 510(k)-cleared and biocompatible. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
    Ask a Question

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