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510(k) Data Aggregation

    K Number
    K081540
    Device Name
    ZEGRA POSTURE TRAINER
    Manufacturer
    PETER FISCHER
    Date Cleared
    2009-02-20

    (263 days)

    Product Code
    LZW,PAN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K951244
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the ZEGRA Posture Trainer is a postural reminder for people who have the habit of slumped posture, who wish to be reminded of their posture whenever they slump beyond a predetermined limit, and who have the ability to correct their posture, The ZEGRA Posture Trainer's feedback helps to reduce slumped posture within this population.

    The intended use is for Prescription Use and Over-The-Counter Use.

    Device Description

    The ZEGRA Posture Trainer is worn and looks just like the predicate posture trainer by the name of SPINE TUNER (510k Number: K951244). It is strapped around the chest with a belt or a bra. All electronic components sit in a little plastic case. The case contains a part that is moved when the user slumps. This movement is picked up by a sensor within the case. When the ZEGRA Posture Trainer is switched on, a microprocessor records the current posture as posture threshold. Thereafter, the ZEGRA Posture Trainer will vibrate whenever this threshold posture is reached or surpassed by slumping too much. The user has a choice of immediate feedback or feedback with a few seconds delay. The ZEGRA Posture Trainer has no cables and no options for connecting with other devices. It is exclusively battery powered.

    AI/ML Overview

    The provided text describes a 510(k) submission for the ZEGRA Posture Trainer (K081540). However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the specific study details outlined in your request.

    The document is primarily a 510(k) summary and the FDA's decision letter, which focuses on device description, intended use, and substantial equivalence to a predicate device. It explicitly states that the predicate device is an "unclassified pre-amendments device" and that the ZEGRA Posture Trainer is expected to be classified in the same way. This type of submission relies on demonstrating substantial equivalence to a legally marketed device rather than providing extensive clinical performance data against specific acceptance criteria.

    Therefore, I cannot populate the table or answer the specific questions about studies, sample sizes, or ground truth as this information is not present in the provided text.

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