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510(k) Data Aggregation

    K Number
    K210825
    Device Name
    Revitive Medic Coach (Model Number 5575AQ)
    Manufacturer
    Actegy, Ltd.
    Date Cleared
    2021-12-17

    (273 days)

    Product Code
    NGX, GZJ, IPF, NUH, NYN
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Actegy, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (1) When using Electrical Muscle Stimulation (NMES), Revitive is intended: · for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping - · to temporarily increase local blood circulation in healthy leg muscles - · to stimulate healthy muscles in order to improve and facilitate muscle performance - · to temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities legs) due to strain from exercise or normal household duties - · for relaxation of muscle spasm, - · for increase of blood flow circulation. - · for prevention or retardation of disuse atrophy, - · for muscle re-education, - · for maintaining or increasing range of motion, and - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - · Provide quadricep strengthening - · Improve knee stability secondary to quadricep strengthening (2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: - · symptomatic relief and management of chronic, intractable pain - · relief of pain associated with arthritis · temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities.
    Device Description
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    K Number
    K192887
    Device Name
    Revitive Medic Plus, Revitive Advanced 2
    Manufacturer
    Actegy, Ltd.
    Date Cleared
    2020-05-04

    (207 days)

    Product Code
    NGX, GZJ, IPF, NUH, NYN
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Actegy, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NMES: - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance. - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - For relaxation of muscle spasm. - Increase of blood flow circulation, - Prevention or retardation of disuse atrophy, - Muscle re-education. - Maintaining or increasing range of motion, - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - For users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping TENS: - For symptomatic relief and management of chronic intractable pain - Relief of pain associated with arthritis - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities
    Device Description
    Not Found
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    K Number
    K190924
    Device Name
    Revitive Medic Plus, Revitive Advanced 2
    Manufacturer
    Actegy, Ltd.
    Date Cleared
    2019-07-05

    (87 days)

    Product Code
    NGX, IPF, NUH, NYN
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Actegy, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NMES: - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance. - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - For relaxation of muscle spasm, - Increase of blood flow circulation, - Prevention or retardation of disuse atrophy, - Muscle re-education, - Maintaining or increasing range of motion, and - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis TENS: - For symptomatic relief and management of chronic intractable pain - Relief of pain associated with arthritis - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities
    Device Description
    Not Found
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    K Number
    K152480
    Device Name
    Revitive Medic; Revitive MV; Revitive LV
    Manufacturer
    Actegy, Ltd.
    Date Cleared
    2016-03-31

    (213 days)

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

    Actegy, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · To temporarily increase local blood circulation in healthy leg muscles · To stimulate healthy muscles in order to improve and facilitate muscle performance. · For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.
    Device Description
    Not Found
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