LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190118
    Device Name
    Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
    Manufacturer
    Guangzhou Xinbo Electronic Co., Ltd.
    Date Cleared
    2020-05-13

    (475 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)

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

    The Cutaneous Electrodes, Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-II, CP-III), are intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS). The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the bottom of the feet which they are in contact with.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to Guangzhou Xinbo Electronic Co., Ltd. regarding the 510(k) premarket notification for their Dr-Ho's Foot Pad Electrode. This document primarily focuses on regulatory approval, classification, and general controls.

    The letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth establishment, or training set details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1