Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220286
    Device Name
    ELECTROCYN soma
    Manufacturer
    Date Cleared
    2022-12-21

    (323 days)

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

    V3bio Sdn. Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rx Indications: Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds. OTC Indications: ELECTROCYN soma is intended for OTC use in the management of skin abrasions, minor irritations, cuts, and intact skin.
    Device Description
    ELECTROCYN soma contains purified water - 99.9%, hypochlorous acid (HOCl) + sodium hypochlorite (NaOCl) + sodium chloride (NaCl) ~ 0.1% and packed in HDPE bottles.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1