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510(k) Data Aggregation

    K Number
    K210979
    Device Name
    Prelivia
    Manufacturer
    Date Cleared
    2021-05-13

    (42 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rehabtronics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Relaxation of muscle spasms; Prevention or retardation of disuse atrophy; Increasing local blood circulation; Muscle re-education; Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; Maintaining or increasing range of motion.
    Device Description
    Not Found
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    K Number
    K153163
    Device Name
    ReGrasp
    Manufacturer
    Date Cleared
    2016-04-07

    (157 days)

    Product Code
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rehabtronics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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