BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    POSTERIOR LEAF SPLINT

    Reg #: 9681624 · FEI: 3002903298 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PERFORMANCE HEALTH INTERNATIONAL LTD
    Registration Number
    9681624
    FEI Number
    3002903298
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NUNN BROOK RD, HUTHWAITE
    City
    SUTTON-IN-ASHFIELD Nottinghamshire
    Country
    GB

    Owner / Operator

    Firm Name
    Performance Health Supply
    Operator Number
    10050734
    Address
    3333 Finley Road, Suite 575
    City
    Downers Grove
    State
    IL
    Postal Code
    60515
    Country
    US
    Correspondent
    Paul Hanneman

    US Agent

    Business Name
    PERFORMANCE HEALTH SUPPLY
    Contact Name
    Paul Hanneman
    Address
    3333 Finley Rd Ste 575
    City
    Downers Grove
    State
    IL
    ZIP
    60515
    Country
    US
    Email
    [email protected]
    Phone
    630 3936015

    Products

    Device Name Product Code
    Orthosis, Limb Brace IQI

    Proprietary Names

    POSTERIOR LEAF SPLINT ROLYAN WEDGE FLEX Rolyan Aquaplast-T Rolyan AquaForm (all types) Rolyan Polyflex II Semi-Compressed Mixed Felt *9 ROLYAN ANKLE FOOT ORTHOSIS ROLYAN STRAPS - ALL CONFIGURATIONS & ACCESSORIES ROLYAN POST SURGICAL ARM SUPPORT Rolyan Synergy Rolyan Aquaplast Prodrape-T Rolyan CuraDrape Rolyan Ezeform Rolyan Polyform Rolyan Aquaplast Original PADDING - ALL THICKNESSES & CONFIGURATIONS Rolyan Aquaplast Resilient-T Rolyan Tailorsplint Rolyan Aquaplast Watercolors ROLYAN DYNAMIC PRONATION/SUPINATION KIT Rolyan Aquaplast Original Resilient ROLYAN INCREMENTAL WRIST HINGE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device