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Class II Medical Limb Compression Sleeve

Class II Medical Limb Compression Sleeve

Product Description

The medical limb compression sleeve can be wrapped around various parts of the body and provides therapy through air compression.

Product Specifications

  • – 2400mA lithium battery
  • – 2 hour to full charge, battery life of 20-24 hours
  • – Power on/off by motion sensor or front switch
  • – Three pressure levels – 40, 50, 55mmHg
  • – Inflates from 0 to 40mmHg in 30 seconds
  • – Deflates in 60 seconds
  • – LCD display shows timer and air pressure levels
    Passed Medical Tests for FDA 510KISO 10993-5:2009 (E)Biological evaluation of medical devices
    Part 5: Tests for in vitro cytotoxicityISO 10993-10:2010 (E)
    Biological evaluation of medical devicesEN 60601-1-2 : 2007/AC:2010
    Medical electrical equipment
    Part 1-2: General requirements for basic safety and essential performance
    Collateral standard: Electromagnetic compatibility – Requirements and tests.

    IEC 60601-1- : 2007
    Medical Electrical Equipment
    Part 1-2: General Requirements For Basic Safety And Essential Performance
    Collateral Standard: Electromagnetic Compatibility
    Requirements And Tests. (General I (QS/RM))

    IEC 60068-2-6
    Environmental testing
    Part 2-6: Tests – Test Fc:Vibration (sinusoidal)

    IEC 60068-2-27
    Environmental testing
    Part 2-27: Tests – Test Ea and guidance: Shock ISTA 2A Standard

    IEC 60068-2-14: 2009
    Environmental testing
    Part 2-14: Tests -Test N: Change of temperature