LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060220
    Device Name
    PBS MODEL 701A COMPRESSION THERAPY DEVICE
    Manufacturer
    MEGO AFEK
    Date Cleared
    2006-02-09

    (10 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PBS MODEL 701A COMPRESSION THERAPY DEVICE

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

    Treatment of Venous disorders and Dysfunction of the "Muscle Pump"

    Device Description

    PBS (Petit Basic System) Model 701 A Compression Therapy Device

    AI/ML Overview

    This document does not contain the information required to answer your request. It is a 510(k) premarket notification letter from the FDA to Mego Afek Ltd. regarding their PBS Model 701A Compression Therapy Device.

    Specifically, the document does not include:

    • A table of acceptance criteria and reported device performance.
    • Details of any study (sample sizes, data provenance, ground truth establishment, expert information, adjudication methods) used to prove the device meets acceptance criteria.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

    The document primarily states that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices for the stated indications for use, thereby permitting the device to proceed to market. It outlines regulatory requirements that the manufacturer must comply with.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1