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510(k) Data Aggregation

    K Number
    K192252
    Device Name
    ProPerformance Recovery System
    Manufacturer
    Date Cleared
    2019-09-19

    (30 days)

    Product Code
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Menlo Brands LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Speed Hound ProPerformance Recovery System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Speed Hound Recovery System simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    This submission is for the Speed Hound ProPerformance Recovery System. The Speed Hound ProPerformance Recovery System is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase in circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The device is a Class II, type BF applied part that receives power through a non-detachable power cord The ProPerformance Recovery System consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment A description of each of these components is provided below. The hardware and software of this device is identical to the model PT1003 by Xiamen Senyang Co., Ltd., cleared under 510(k) K181409 The "garments" (leg, arm and hip) and the plastic air tubing are of identical materials to the components of the FDA-cleared PT1003 (K181409).
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