BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Gymform Total ABS

    DI: 06973698290081 · Model: VDPGYCIND0132 · Well Brain International Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gymform Total ABS
    Primary DI
    06973698290081
    Version / Model
    VDPGYCIND0132
    Company Name
    Well Brain International Limited
    Labeler DUNS
    663213551
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-26
    Public Version
    3
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    02da20ff-8fb9-4cce-b093-c742987b44ba
    Distribution End Date
    2023-04-25

    Device Description

    An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to temporarily strengthen, tone or firm muscles in a complimentary way.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 06973698290081

    Premarket Submissions

    Submission Number Supplement Number
    K202653 000