LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980769
    Device Name
    WINDMERE MODEL DS-2 FOOT BATH
    Manufacturer
    WINDMERE CORP.
    Date Cleared
    1998-03-27

    (28 days)

    Product Code
    ILJ
    Regulation Number
    890.5100
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hydrotherapy; Professional footbath for a relaxing aqua massage. Ideal for pedicure preparation. Gently massages soles of feet, comforts soles of feet, soothing relief for tired feet.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the Windmere Model DS-2 Foot Bath (K980769). This type of document does not contain acceptance criteria or a study proving the device meets acceptance criteria.

    The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means that the device is deemed safe and effective for its intended use based on its similarity to previously cleared devices, rather than through a direct study demonstrating its performance against specific acceptance criteria.

    The "Indications for Use" section (page 2) describes what the foot bath is intended for (Hydrotherapy; Professional footbath for a relaxing aqua massage, etc.) and lists contraindications, but these are not performance metrics or acceptance criteria for a study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1