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510(k) Data Aggregation

    K Number
    K964437
    Device Name
    GB-1002 TENS WITH MASSAGE
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1998-08-14

    (647 days)

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

    GB-1002 TENS WITH MASSAGE

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

    TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DE VICES ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (I ONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS. A THERAPEUTIC VIBRATOR IS INTENDED FOR RELAXING MUSCLES AND RELIEVING MINOR MUSCLE ACTIES AND PAINS.

    Device Description

    GB-1002 TENS WITH VIBRATOR

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the GB-1002 Tens with Vibrator device. It states that the device is substantially equivalent to a predicate device already on the market.

    However, this document does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove device performance.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance process based on substantial equivalence, not on specific performance metrics or clinical study results.

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