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510(k) Data Aggregation

    K Number
    K222669
    Device Name
    Cryopush Cold Compression Device
    Date Cleared
    2022-12-05

    (90 days)

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

    Chengdu Cryo-Push Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A02-P-001: The Cryopush Cold Compression Device is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable. A02-P-002: The Cryopush A02-P-002 is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap.
    Device Description
    Cryopush Cold Compression Device consists of a main unit and wraps which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. It is for temporary increase in circulation of the treated areas and temporary relief of minor muscle aches and pains. By inflating the air chambers and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The device includes two models A02- P-001 and A02- P-002. The A02- P-001 has one chamber, and A02- P-002 has 2 chambers. The A02- P-001 contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable. When the A02- P-001 is used for 30 minutes (Default time) at the operating temperature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18℃~-4℃) (±2℃).
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