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510(k) Data Aggregation

    K Number
    K151279
    Device Name
    Counter OTC TENS Device, Model CSD-737Z
    Manufacturer
    COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD
    Date Cleared
    2015-12-16

    (216 days)

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

    Counter OTC TENS Device, Model CSD-737Z

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

    To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 4.

    To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 1 or Auto 3..

    To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes A, B, E or Auto 1 or Auto 4.

    To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes A and C or Auto 1, Auto 2, Auto 3, or Auto 4.

    To be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode A or Mode B.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the substantial equivalence of the device to legally marketed predicate devices and includes the "Indications for Use" for the device.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies. These types of details are typically found in the accompanying technical documentation or clinical study reports submitted as part of the 510(k) application, which are not present here.

    Therefore, I cannot provide the requested information from this document. The prompt asks to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" based on the input, but this input does not contain that specific information.

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