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510(k) Data Aggregation

    K Number
    K021755
    Device Name
    APEX MEDICAL DIGITAL TENS TS1211, TS1212
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2002-06-12

    (14 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    APEX MEDICAL DIGITAL TENS TS1211, TS1212

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

    Apex Medical Digital TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device, Apex Medical Digital TENS Models TS-1211 and TS-1212, is substantially equivalent to legally marketed predicate devices.

    The letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details typically found in a clinical or performance study report. The primary purpose of a 510(k) clearance letter is to state that the device is substantially equivalent to a predicate device, not to detail the results of its performance testing.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

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