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510(k) Data Aggregation

    K Number
    K243112
    Device Name
    Curapuls 670
    Manufacturer
    Enraf-Nonius, B.V.
    Date Cleared
    2025-06-25

    (268 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enraf-Nonius, B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curapuls 670 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
    Device Description
    The Curapuls 670 is a two-channel microprocessor-controlled unit for pulsed shortwave therapy. Through inductive electrodes (Circuplodes), high-frequency electric currents are produced within the body. Pulsed energy at 27.12 MHz is absorbed by soft tissues. Three sizes of Circuplodes (140mm, 90mm and elliptical) are available to accommodate different size treatment areas. Deep heating of tissue is achieved with ease by means of inductive electrodes. The user can connect two applicators. Activation of each applicator can be controlled from the console menu. This device is a prescription equipment. Use by any persons other than physicians is prohibited.
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    K Number
    K230472
    Device Name
    Sonopuls 190
    Manufacturer
    Enraf-Nonius, B.V.
    Date Cleared
    2023-10-24

    (244 days)

    Product Code
    IMI, CLA
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enraf-Nonius, B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Therapeutic Ultrasound is indicated for: • Pain Relief • Reduction of muscle spasms • Localized increase in blood flow • Increase range of motion of contracted joints using heat and stretch techniques
    Device Description
    This device is a multi-frequency ultrasound therapy equipment. The mounted applicators provide both 1 and 3 MHz operation. Depending on the area of treatment, two different types of applicators, large and small, are available. They are suitable for treatment under water. Contact control suspends the application of ultrasound energy when acoustical contact with the treatment area becomes insufficient. The user can connect two ultrasound applicators. Activation of each applicator can be controlled from the ultrasound menu. This device is a prescription equipment. Use by any persons other than physicians is prohibited.
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