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510(k) Data Aggregation

    K Number
    K080950
    Device Name
    STIWELL MED4
    Manufacturer
    OTTO BOCK, AUSTRIA GMBH
    Date Cleared
    2009-04-02

    (364 days)

    Product Code
    IPF,GZI,GZJ,HCC,KPI
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K032954,K053434,K040849,K940301,K032988,K031900
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK, AUSTRIA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.

    As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions:

    • Relaxation of muscle spasm
    • Prevention or retardation of disuse atrophy
    • Increasing local blood circulation
    • Muscle re-education
    • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    • Maintaining or increasing range of motion

    As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:

    • Symptomatic relief and management of chronic (long-term), intractable pain
    • Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

    As a biofeedback device the STIWELL med4 is indicated for the following conditions:

    • Biofeedback, relaxation and muscle re-education purposes

    As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions:

    • Helps to relearn voluntary motor functions of the extremities

    As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions:

    • Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
    • Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles
    Device Description

    The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.

    The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the STIWELL med4, a neuromuscular electronic stimulator. It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding clinical study design, performance metrics, and expert adjudication is not present in this type of submission.

    Here's an analysis based on the available information:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device has the same intended use and the same technological characteristics as the predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as a legally marketed device.

    The document provides extensive tables comparing the STIWELL med4's technical characteristics across various stimulation programs (Functional Electrical Stimulation, Incontinence, TENS, Biofeedback) with its predicate devices. The "performance" in this context is the successful demonstration that these characteristics are similar enough to existing devices to not introduce new safety or effectiveness concerns.

    Summary Table of Equivalence (Acceptance Criteria are inferred from predicate device characteristics):

    Characteristic/Program TypeAcceptance Criteria (inferred by predicate)STIWELL med4 Performance (Reported)Notes
    General Unit Characteristics
    Power SourceBattery Pack (NiMH or Alkaline)Battery Pack Li-Ion 11,1VDifferent battery chemistry, but the submission implicitly argues it does not raise new safety/effectiveness concerns.
    Method of Line Current IsolationMedical Class II Power Adapter/N/AMedical Class II Power AdapterConsistent.
    Patient Leakage CurrentN/A (Battery)N/A (Battery)Consistent.
    Number of Output Modes11Consistent.
    Number of Output Channels2 or 44Consistent with some predicates, exceeds others (e.g., Elpha II3000 has 2).
    Number of EMG (input) Channels1 or 2 (or N/A)2Consistent with predicates that have EMG (e.g., Myotrac Infinity, Mentamove).
    EMG Sensitivity
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