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510(k) Data Aggregation

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

    (263 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PETER FISCHER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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