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510(k) Data Aggregation

    K Number
    K153163
    Device Name
    ReGrasp
    Manufacturer
    Rehabtronics Inc.
    Date Cleared
    2016-04-07

    (157 days)

    Product Code
    GZI,IPF
    Regulation Number
    882.5810
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ReGrasp is an electrical stimulation device indicated for the following uses:

    Functional Electrical Stimulation (FES):

    • Improvement of hand-function and active range of motion in patients with hemiplegia or upper limb paralysis due to stroke, traumatic or acquired brain injury, or C5 level cervical spinal cord injury.

    Neuromuscular Electrical Stimulation (NMES):

    • Maintenance and/or increase of range of motion
    • Prevention and/or reduction of disuse atrophy
    • Increase of local blood circulation
    • Reduction of muscle spasms
    • Muscle re-education
    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the ReGrasp device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device, not on specific performance criteria derived from a clinical study as would be seen for a PMA.

    Therefore, I cannot provide the requested information from the given document.

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