Product Overview

SofCare - 2760-100-000


Device Description

A device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -40.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FMP

    Device Name: Protector, Skin Pressure

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: HO

    Review Code: N/A

    Technical Method: Y

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 880.6450

    Third Party Flag: N

    Medical Specialty: HO


    Device Identifiers

    Device Id: 57613327278533

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 07613327278538

    Package Quantity: 6

    Package Discontinue Date: 9/26/2023 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: case


    Device Id: 07613327278538

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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