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510(k) Data Aggregation

    K Number
    K140780
    Device Name
    KEGEL SMART, KEGELSMART PEARL
    Manufacturer
    REGULATORY INSIGHT, INC.
    Date Cleared
    2014-09-10

    (166 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY INSIGHT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intimina KegelSmart and Intimina KegelSmart Pearl are intended for independent use by women at home to strengthen pelvic floor muscles to treat stress and/or urge urinary incontinence.
    Device Description
    The Intimina KegelSmart and KegelSmart Pearl are pelvic floor muscle exercise devices that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.
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    K Number
    K112505
    Device Name
    ETHEREA
    Manufacturer
    REGULATORY INSIGHT, INC.
    Date Cleared
    2012-04-06

    (220 days)

    Product Code
    GEX, ILY, ONF
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY INSIGHT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intense Pulsed Light (IPL-sq): - Treatment mild to moderated inflammatory and pustular inflammatory acne vulgaris. - The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles). - Lentigines, nevi, and café-au-lait macules. - The treatment of cutaneous lesions including warts, scars and striae. - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, and venous malformations. - The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction. Infrared (Intense IR): Topical heating for the purpose of elevating tissue's temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase of local circulation where applied, and the relaxation of muscles. In addition, may also help muscle spasms, minor sprains and strains, and minor muscular back pain. Laser Nd:Yag 1064nm (1064 LongPulse): - Coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of superficial and deep telangiectasias, reticular veins (0,1- 4 mm diameter) of the leg, rosacea, warts, venous lake, leg veins, poikiloderma of Civatte, angiomas, hemangiomas, and nevus; - Non ablative treatment of facial wrinkles, scars and striae; - The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction; - Treatment of pseudofolliculitis barbae.
    Device Description
    Not Found
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    K Number
    K020094
    Device Name
    EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS
    Manufacturer
    REGULATORY INSIGHT, INC.
    Date Cleared
    2002-03-08

    (56 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY INSIGHT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EN 600-658, EN 600-666, EN 600-664, EN 600-664, EN 600-690, EN 600-6 151, EN 600-663, EN 600-665 and EN 600-670 Mechanical Wheelchats are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    Not Found
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    K Number
    K020100
    Device Name
    SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
    Manufacturer
    REGULATORY INSIGHT, INC.
    Date Cleared
    2002-03-08

    (56 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY INSIGHT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 Mechanical Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    Not Found
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