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510(k) Data Aggregation

    K Number
    K233034
    Device Name
    Mobility+ Enteral Feeding System OTC
    Manufacturer
    Rockfield Medical
    Date Cleared
    2024-04-12

    (200 days)

    Product Code
    PIF, KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rockfield Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mobility+ is intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over.
    Device Description
    The Mobility+ Enteral Feeding System OTC ("Mobility+ OTC" or the "System") is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24-hour period. The System has three primary components; food pouch, filling set and giving set. Food Pouch: The Food Pouch serves as the Mobility+ Enteral Feeding System OTC system's combined reservoir and pump. The pouch consists of a foil container with an internal elastomeric pouch. The Food Pouch can hold up to 500 ml of feed. Filling Set: The Filling Set is tubing that connects to the Mobility+ food pouch to deliver commercially available nutritional feed from its packaging to the Food Pouch using ENFit connectors. The Filling Set is used to transfer feed from the feed packaging into the Food Pouch, using a syringe. Giving Set: The Giving Set is tubing that connects the Food Pouch to the implanted feeding tube's ENFit connector. The Giving Sets will be available in a variety of lengths to give a range of feed flow rates. All connectors in the Mobility+ Enteral Feeding System OTC comply with the FDA-recognized ENFit standard (ISO 80369-3 and ISO 18250-3). The Mobility+ Enteral Feeding System OTC may be worn in a bag of choice that can fit the system without kinking the tubing and without squeezing the pouch. The instructions for use guide the user to place the spout of the pouch within 15cm (6 inches) above or below the stoma when feeding.
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    K Number
    K222678
    Device Name
    Mobility+ Enteral Feeding System
    Manufacturer
    Rockfield Medical
    Date Cleared
    2022-10-27

    (51 days)

    Product Code
    PIF, KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rockfield Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mobility+ is intended to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.
    Device Description
    The Mobility+ Enteral Feeding System ("Mobility+" or the "System") is a portable, lightweight, nonelectronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in the clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24 hour period. The System has three primary components; food pouch, filling set and giving set.
    Ask a Question

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