BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Back on Track ankle brace

    Reg #: 3009809406 · FEI: 3009809406 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BACK ON TRACK BOT LLC
    Registration Number
    3009809406
    FEI Number
    3009809406
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    350 Circle of Progress Drive
    City
    Pottstown
    State
    PA
    ZIP
    19464
    Country
    US

    Owner / Operator

    Firm Name
    Back on Track BOT LLC
    Operator Number
    10046578
    Address
    350 Circle of Progress Drive
    City
    Pottstown
    State
    PA
    Postal Code
    19464
    Country
    US
    Correspondent
    James Ruder

    Products

    Device Name Product Code
    Joint, Ankle, External Brace ITW

    Proprietary Names

    Back on Track ankle brace Back on Track knee brace with strap Back on Track calf brace Back on Track wrist brace Back on Track elbow brace Back on Track knee brace

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device