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510(k) Data Aggregation

    K Number
    K992652
    Device Name
    SD-730 IF-SDS, PERFECT PULSE IF-SDS
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2000-02-03

    (181 days)

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

    SD-730 IF-SDS, PERFECT PULSE IF-SDS

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

    1.Symptomatic relief of chronic, intractable pain

    2.Management of pain associated with post-traumatic or post-operative conditions

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named SD-730 IF-SDS (also known as Perfect Pulse IF-SDS). This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

    However, the document does NOT contain information about acceptance criteria, specific device performance data from a study, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth used, or training set information.

    The document is a regulatory approval letter, not a study report. It outlines the indications for use for which the device was cleared ("Symptomatic relief of chronic, intractable pain" and "Management of pain associated with post-traumatic or post-operative conditions") but does not present the data used to support these claims or demonstrate performance against specific criteria.

    Therefore, I cannot provide the requested information based on the text provided.

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