Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K152628
    Device Name
    Pulse H20h!
    Manufacturer
    Date Cleared
    2016-07-11

    (300 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOASTER LABS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This personal lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    The Pulse H2Oh! is a personal lubricant intended for overthe-counter sale. It is sold, and used, not sterile. The lubricant is colorless to slightly yellow and unfragranced. The product is used for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. The Pulse H2Oh! lubricant is supplied in the form of individual plastic pump canisters, called pods. A pod is ~2.5 inches tall, has a diameter of ~1 inch and contains ~6.7 ml of lubricant. The pod pump allows the user to receive an aliquot of lubricant without touching the nozzle or inside of the container. The Pulse H2Oh! lubricant is a gel with a pH of 4.8 - 5.2, and is comprised of the following ingredients: - Purified water - Propanediol / Zemea Propanediol ● - Hydroxyethylcelluose / Natrosol 250H Pharm ● - Potassium Sorbate ● - Chia Seed Extract ● - Citric Acid ● Device specifications are: color, odor, appearance, weight gain/loss % (w/w), pH, specific gravity, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of specified microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.
    Ask a Question

    Ask a specific question about this device

    K Number
    K152671
    Device Name
    Pulse Aloe-ahh
    Manufacturer
    Date Cleared
    2016-07-11

    (297 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOASTER LABS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    for the indications for use stated in the enclosure
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1