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510(k) Data Aggregation

    K Number
    K252289

    Validate with FDA (Live)

    Device Name
    Eva Scalp Cooling System
    Manufacturer
    Stemtech Medical Devices Private Limited
    Date Cleared
    2025-11-25

    (125 days)

    Product Code
    PMC
    Regulation Number
    878.4360
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K191166
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Eva Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.

    Device Description

    The Eva Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. The Eva Scalp Cooling System is a cooling unit with a built-in control system. It can be operated using a touch-screen display. The device maintains a cooling temperature between -3°C and 1°C, and the treatment time can be adjusted by the doctor for before, during, and after chemotherapy. The treatment time also can be adjusted by doctor for different cancer types and drug types. The system features a computerized control unit that keeps the scalp temperature steady during treatment.

    AI/ML Overview

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