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510(k) Data Aggregation

    K Number
    K211526
    Device Name
    Portable Scalp Cooling System
    Manufacturer
    Cooler Heads Care, Inc.
    Date Cleared
    2021-10-21

    (157 days)

    Product Code
    PMC
    Regulation Number
    878.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cooler Heads Care, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Portable Scalp Cooling System (PSCS) is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. The PSCS is indicated for adult patients only.
    Device Description
    The Portable Scalp Cooling System (PSCS) is a wearable device for people undergoing chemotherapy treatment for solid tumor cancer who want to avoid chemotherapy-induced hair loss, or alopecia. Treatment with the PSCS is administered by a user or caregiver in a treatment center, during travel time to the patient's home and in the home setting. It is designed for continual use during the transition from the infusion center to the patient's home. The portable device provides the cooling therapy by circulating a water/isopropyl alcohol (IPA) mixture through a cooling cap worn securely on the patient's head.
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