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510(k) Data Aggregation

    K Number
    K221653
    Device Name
    InfaTherm Disposable Infant Warming Mattress
    Manufacturer
    International Biomedical
    Date Cleared
    2022-10-06

    (121 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InfaTherm™ Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.
    Device Description
    The InfaTherm™ Disposable Infant Warming Mattress is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and water and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the nontoxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, the Infant warming mattress will reach between 100-102°F and then gradually decrease in temperature over time. The InfaTherm™ Disposable Infant Warming Mattress is rectangular in shape. Immediately following activation of the mattress, the user places the infant on the mattress.
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    K Number
    K163295
    Device Name
    Infant Transport Mattress Warmer with Disc
    Manufacturer
    RAPID AID CORP.
    Date Cleared
    2017-07-24

    (244 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rapid Aid Infant Transport Mattress Warmer with Disc provides warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants.
    Device Description
    The Rapid Aid Infant Transport Mattress Warmer with Disc (Infant Transport Mattress) is a rectangular pad that is intended to provide warmth during transport of an infant within a hospital or between hospitals. The single-use disposable device consists of an outer pouch with a liquid solution activated by bending an activator disc; an exothermic reaction warms the Infant Transport Mattress to no higher than 104°F (range 101°F to 104°F) for a dwell time of ≥10 minutes.
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    K Number
    K112547
    Device Name
    NEO NEST
    Manufacturer
    DENOVO PROUCTS LLC
    Date Cleared
    2012-03-06

    (187 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.
    Device Description
    Neo Nest Infant Transport Mattress
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    K Number
    K082087
    Device Name
    EYEFEEL OPHTHALMIC WARMER
    Manufacturer
    BIO-LIPID, INC.
    Date Cleared
    2008-09-11

    (50 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.
    Device Description
    The EyeFeel Warmer consists of a front layer, two oval shaped sacks that hold the iron powder mixture, and a back inner layer that is placed on the face. The iron powder mixture consists of iron powder, sodium chloride, filtrated water, powdered activated carbon, granular activated carbon, sodium polyacrylate powder, and exfoliated vermiculite.
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    K Number
    K071710
    Device Name
    BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.
    Date Cleared
    2007-08-14

    (53 days)

    Product Code
    IMD, PRE
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Is intended for over-the-counter (non-prescription) use by the consumer. Provides moist heat therapy to temporarily relieve minor muscle and joint aches and pain associated with over-exertion, strains, sprains, arthritis, stiffness, and muscle spasm. Temporarily relieves minor menstrual pain. Temporarily increases local blood circulation.
    Device Description
    BENGAY™ Heat Therapy is a disposable, single-use, airactivated pain relieving patch which adheres to the skin by means of a hydrogel adhesive and generates heat by the oxidation of iron powder. The device consists of 6 components: - Oxygen-impermeable, primary packaging; . - . Breathable fabric sachet containing the heating element mixture; - Heating element mixture; . - Backing sheet which separates the heating element . mixture from the hydrogel layer; - . Hydrogel layer to provide adhesion to the skin surface; and, - Release liner to protect the adhesive hydrogel laver . prior to consumer use When the air-tight, protective packaging is opened, the heating element mixture reacts with oxygen in the air, and the patch begins to warm up. It takes up to 30 minutes for the patch to reach its target temperature range. The patch stays warm for at least 8 hours. BENGA Y™ Heat Therapy reaches its target temperature range in 30 minutes or less, and remains in this temperature range for a minimum of 8 hours. BENGAY™ Heat Therapy provides moist heat as demonstrated by user perception and laboratory experiments.
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    K Number
    K021843
    Device Name
    EYEFEEL OPHTHALMIC WARMER
    Manufacturer
    BIO-LIPID, INC.
    Date Cleared
    2002-09-03

    (90 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeFeel™ Ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eye lids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
    Device Description
    The EyeFeel Ophthalmic Warmer is a simple device for application of heat therapy to the eye. It is shaped as a kind of "mask" to fit over the eyes, and consists of layers of synthetic paper, which surround a "sac" containing an iron powder mixture. Oxidation of the iron powder mixture generates heat.
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    K Number
    K982652
    Device Name
    ALLEGIANCE PORTA-WARM MATTRESS
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    1999-01-21

    (175 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.
    Device Description
    The Porta-Warm™ Mattress consists of a heat source housed in a plastic pouch. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, thus creating a physical exothermic reaction.
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    K Number
    K980509
    Device Name
    DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Date Cleared
    1998-02-26

    (16 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeRoyal Industries Inc. Infant Transport Mattress is to be used to assist in maintaining infant body temperature.
    Device Description
    The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature. Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).
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    K Number
    K974190
    Device Name
    CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
    Manufacturer
    CONSOLIDATED PRODUCTS & SERVICES, INC.
    Date Cleared
    1997-11-19

    (15 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CP&S Disposable Ice Pack Limb Kit Transporter provides an environment above freezing for a severed body part while being transported to the hospital emergency room or replantation surgery.
    Device Description
    The CP&S Disposable Instant Ice Pack Limb Kit Transporter is an instant ice pack with an added pouch for the insertion of a severed body part for transport to the hospital emergency room or replantation surgery. The Instant Cold Pack Limb Kit Transporter is activated in the same manner as the Disposable Instant Cold Pack and provides cooling for the severed limb within the gauze lined zip lock top bag. A cool environment above freezing is maintained for approximately 30 minutes. The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack.
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    K Number
    K973770
    Device Name
    ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    1997-11-13

    (42 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    IMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an an episiotomy.
    Device Description
    The Allegiance Kwik Heat™ Perineal Warm Pack is comprised of an outer pouch which is secured to a perineal pad and then wrapped in a polyester material. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, and kneading the unit, thus creating a physical exothermic reaction.
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