BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DS8

    Reg #: 3017520337 · FEI: 3017520337 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Slow Wave, Inc.
    Registration Number
    3017520337
    FEI Number
    3017520337
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22111 Tx Hwy 71 W Ste 104
    City
    Spicewood
    State
    TX
    ZIP
    78669
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240463

    Owner / Operator

    Firm Name
    Slow Wave, Inc.
    Operator Number
    10078388
    Address
    26100 Countryside Dr.
    City
    Spicewood
    State
    TX
    Postal Code
    78669
    Country
    US

    Products

    Device Name Product Code
    Mouthguard, Migraine/Tension Headache OCO
    Mouthguard, Prescription MQC

    Proprietary Names

    DS8 BROSA

    Establishment Types

    Manufacture Medical Device