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510(k) Data Aggregation

    K Number
    K984190
    Device Name
    BACK-ON-TRAC, MODEL 101BOT
    Manufacturer
    BACK-ON-TRACK, INC.
    Date Cleared
    1999-03-15

    (112 days)

    Product Code
    HST,FEB
    Regulation Number
    888.5850
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BACK-ON-TRACK, INC.

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

    The BACK - ON - TRAC is intended for the treatment of acute and chronic low back pain of disc origin or due to malalignments of the apophyseal joints.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "BACK-ON-TRAC". It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance, or specific studies conducted.

    Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed based on its substantial equivalence to pre-existing devices, but it does not detail the technical performance or the studies used to demonstrate that performance.

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