Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982321
    Date Cleared
    1999-02-01

    (214 days)

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

    VECTRA STIM MODELS 200 AND 400

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

    For VMS, Russian, Monophasic Hi-Volt

    • Relaxation of muscle spasms
    • Prevention or retardation of disuse atrophy
    • Increasing local blood circulation
    • Muscle re-education
    • Maintaining or increasing range of motion
    • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
      For Microcurrent, Interferential and Premodulated
    • Symptomatic relief of chronic, intractable pain
    • Management of pain associated with post-traumatic or post-operative conditions
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Vectra 2C, 4C, 2S, 4S, Pro 2, and Pro 4). This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

    The letter primarily indicates that the devices are substantially equivalent to pre-amendment devices and can be marketed subject to general controls. It lists the indications for use of the devices but does not provide details on studies that support these indications or specific performance metrics.

    Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study data based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1