BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SuperPole™ with SuperTrapeze™

    DI: 00689281020596 · Model: STP-S · Healthcraft Products Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SuperPole™ with SuperTrapeze™
    Primary DI
    00689281020596
    Version / Model
    STP-S
    Catalog Number
    02059
    Company Name
    Healthcraft Products Inc.
    Labeler DUNS
    252468293
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-30
    Public Version
    1
    Public Version Date
    2021-09-07
    Public Version Status
    New
    Public Device Record Key
    01bfa9f2-2e3c-41ec-8bb0-b00790eb0d0d

    Device Description

    The SuperTrapeze is a high quality, commercial grade over-bed trapeze that connects to the SuperPole (floor to ceiling safety pole). The SuperTrapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can hook around the pole to store out of the way when not in use. The SuperTrapeze handle is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The SuperTrapeze handle is installed onto the SuperPole by securing a support arm to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the support arm in place, and the spring ring is used to prevent the set screws from back-threading. The support arm has an adjustable strap that attaches to the trapeze handle. The SuperTrapeze handle is strong enough to support the user when sitting up in bed and standing. It is important to set proper height and orientation of the SuperTrapeze to optimize the user’s range of motion. The maximum user weight for this product is 300lbs / 136kgs. Note: Product is not intended to support full body weight.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMR Device, Transfer, Patient, Manual

    GMDN Terms

    Code Name
    35586 Hand rail

    Identifiers

    Type ID
    Primary 00689281020596