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510(k) Data Aggregation

    K Number
    K232091
    Device Name
    JO Coconut Hybrid Cooling Personal Lubricant
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2023-10-22

    (101 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Coconut Hybrid Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    JO Coconut Hybrid Cooling Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. JO Coconut Hybrid Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL bottle. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Polyisobutene, Polysorbate 20, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Beeswax Glyceryl Stearate, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, PEG45M, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin and Polyquaternium-67.
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    K Number
    K232090
    Device Name
    JO Coconut Hybrid Warming Personal Lubricant
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2023-10-11

    (90 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Coconut Hybrid Warming Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    JO Coconut Hybrid Warming Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. JO Coconut Hybrid Warming Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Niacin, Polyisobutene, Polysorbate 20, Dipropylene Glycol, Vanillyl Butyl Ether,PEG-45M, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Polysorbate 80, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin, Beeswax, Glyceryl Stearate, Hydroxypropylcellulose, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, Polyquaternium-67.
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    K Number
    K230674
    Device Name
    JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2023-05-08

    (59 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Water Based Anal Thick Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    JO Water Based Anal Thick Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. JO Water Based Anal Thick Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./ 60 mL, 4 fl. oz./120 mL and 8 fl. oz./ 240 mL bottles. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle and capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethyl cellulose, Chlorphenesin, Vitamin E Acetate and Sodium Hydroxide.
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    K Number
    K221908
    Device Name
    JO CUMPLAY Personal Lubricant
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2022-09-20

    (82 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO CUMPLAY Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    JO CUMPLAY Personal Lubricant is a non-sterile, water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water (Aqua), Propylene Glycol, Dimethicone, Dimethiconol, Lauryl Glucoside, Aloe Barbadensis Leaf Powder, Vitamin E Acetate, Hydroxyethylcellulose, PEG-90M, Hydrogenated Polydecene, Acrylic Copolymer, Sodium Acrylates/Beheneth-25 Metharylate Crosspolymer, and Chlorphenesin. JO CUMPLAY Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in a 4 fl. Oz./120 mL polyethylene terephthalate bottle and capped with matte black Polypropylene (PP) pump closure.
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    K Number
    K212885
    Device Name
    Actively Trying Personal Lubricant Rose Scented
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2022-02-11

    (154 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Actively Trying Personal Lubricant Rose Scented is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Rose Scented is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose, Arabinogalactan, and Rose water (Damascena).
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    K Number
    K212705
    Device Name
    Actively Trying Personal Lubricant Unfragrance
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2022-02-09

    (167 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Actively Trying Personal Lubricant Unfragranced is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Unfragranced is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose and Arabinogalactan.
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    K Number
    K210972
    Device Name
    H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2021-06-10

    (71 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
    Device Description
    H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. These devices are composed of water (aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Capsicum Frutescens Fruit Extract and PEG-60 Hydrogenated Castor Oil.
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    K Number
    K210986
    Device Name
    H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2021-06-10

    (70 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
    Device Description
    H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. H2O Anal Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. JO 2 To Tango for Me is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. #LubeLife Sensations Cooling is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process. #LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process. These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.
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    K Number
    K200894
    Device Name
    Agape Cooling Personal Lubricant
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2020-07-02

    (90 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Agape Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Agape Cooling Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. The device is provided in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in clear polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This device is composed of Water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Mentha Piperita (Peppermint) Leaf Extract.
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    K Number
    K200602
    Device Name
    Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2020-06-03

    (86 days)

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

    CC Wellness LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premium Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene and polyurethane condoms. Premium Anal Cooling Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
    Device Description
    Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are clear, semi-viscous personal lubricants that are compatible with natural rubber latex, polyisoprene and polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. Premium Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. Premium Anal Cooling Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. These devices are composed of Dimethicone, Dimethiconol and Menthol.
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