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510(k) Data Aggregation

    K Number
    K990445
    Device Name
    LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
    Manufacturer
    LPG USA, INC.
    Date Cleared
    2000-01-18

    (342 days)

    Product Code
    ISA
    Regulation Number
    890.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LPG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves minor muscle aches and pains; Relieve muscle spasm; Temporarily Improve local circulation; Temporarily reduces the appearance of cellulite; Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during Burn rehabilitation
    Device Description
    The LPG devices are intended for practitioners who work in specific fields but all are substantially equivalent devices: ES1 for Endermologie; Cellu M6 for Endermologie and therapeutic applications; S6 sport for sport applications, before, after exercise and rehabilitation after injuries; ES/M60 for therapeutic applications and cosmetic applications on the face or on small area; LPG Equine for animal treatment. These devices are substantially equivalent to the ES1 therapeutic massager because the mode of operation and operating parameters and specifications are basically the same. Each LPG device comprises a main console housing a vacuum pump and a computerized regulation system. All of them contain treatment heads (from 5 to 12), that are designed to accommodate all parts of the body. ES1, Cellu M6, S6, LPG Equine devices have a main motorized head, the other device contain auxiliary heads (non-motorized) only. The equine device head is the largest in order to be able to be applied on the horse's body surface. The suction power of all these machines range from 50mBar to 500mBar which is represented by a scale from 1 to 10; for a specific machine and application, the suction power must be cyclically interrupted to provide vibration to the skin which is another stimulation for the tissues.
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