LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231136
    Device Name
    Fitness Belt (Model: KLT-07)
    Manufacturer
    Shenzhen KeLuTongDa Industrial Co.,Ltd.
    Date Cleared
    2023-06-16

    (56 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Fitness Belt (Model: KLT-07)

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

    The Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.

    • The big belt is intended for use on the muscles in abdomen.
    • The small belt is intended for use on the muscles in arms and thighs areas.
      Contraindicated use on injured or otherwise impaired muscles.
      Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
    Device Description

    Fitness Belt (Model: KLT-07)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Fitness Belt (Model: KLT-07)". This letter confirms the device's substantial equivalence to legally marketed predicate devices.

    However, the letter does not contain any information regarding the acceptance criteria or a study that proves the device meets those criteria, specifically concerning performance metrics like clinical accuracy, sensitivity, specificity, or any evaluation of an AI-powered component. The Fitness Belt is described as a "Powered Muscle Stimulator" and its indications for use are "improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles." This type of device typically undergoes electrical safety, electromagnetic compatibility (EMC), and performance testing related to its electrical stimulation output (e.g., waveform, intensity, frequency), rather than a clinical study involving ground truth or expert consensus in the way an AI-driven diagnostic device would.

    Therefore, I cannot provide the requested information from the given text. The details you're asking for (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size and ground truth establishment) are typical for AI/ML-based medical devices, especially those involved in diagnostic imaging or analysis. This document is for a physical stimulator device, which has very different regulatory and testing requirements.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1