BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HELAVO CORPORATION

    Reg #: 3022159079 · FEI: 3022159079 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    HELAVO CORPORATION
    Registration Number
    3022159079
    FEI Number
    3022159079
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    444 Brickell Avenue Suite 700
    City
    Miami
    State
    FL
    ZIP
    33131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232193

    Owner / Operator

    Firm Name
    Helavo Corporation
    Operator Number
    10084712
    Address
    444 Brickell Avenue Suite 700
    City
    Miami
    State
    FL
    Postal Code
    33131
    Country
    US
    Correspondent
    Nick Hoppner

    Products

    Device Name Product Code
    Walker, Mechanical ITJ
    Wheelchair, Powered ITI

    Proprietary Names

    helavo Electric Wheelchair Dual Battery H2010 helavo Electric Wheelchair Magnesium H2320

    Establishment Types

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