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510(k) Data Aggregation

    K Number
    K965187
    Device Name
    SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
    Manufacturer
    SPARTA SURGICAL CORP.
    Date Cleared
    1997-08-01

    (220 days)

    Product Code
    GZJ,84G
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For symptomatic relief and management of chronic pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

    Device Description

    Spectrum II, Spectrum Plus, and Spectrum MAX-SD TENS devices

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for TENS devices (Spectrum II, Spectrum Plus, and Spectrum MAX-SD). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself or in a summary document that details the testing and validation performed to demonstrate substantial equivalence.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them based solely on the text provided.

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