BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tri-Wave Combination Stimulator

    DI: 00860019001609 · Model: EMS100 · ELITE MEDICAL SUPPLY OF NY
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tri-Wave Combination Stimulator
    Primary DI
    00860019001609
    Version / Model
    EMS100
    Company Name
    ELITE MEDICAL SUPPLY OF NY
    Labeler DUNS
    608469891
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-16
    Public Version
    7
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    bcdac13c-4a6c-4195-b75e-5d9e95530741

    Device Description

    The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    LIH Interferential Current Therapy
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system
    36737 Interferential electrical stimulation system

    Identifiers

    Type ID
    Package 00860019001623
    Primary 00860019001609

    Customer Contacts

    Phone
    716-712-0881
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K171387 000