LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992099
    Device Name
    BIO SPA INTELLIGENT
    Manufacturer
    STARBENE
    Date Cleared
    2002-01-18

    (942 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MUSCLE STIMULATION THERAPY DELIVERED BY THE BIO SPA INTELLIGENT DEVICE IS INDICATED FOR THE FOLLOWING USES :

    • 1- Relaxation of Muscle Spasm
    • 2- Prevention or retardation of disuse atrophy
    • 3- Increasing local blood circulation
    • 4- Muscle re-education
    • 5- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and
    • 6- Maintaining or increasing range of motion
    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to an FDA 510(k) clearance for a device called "Bio Spa Intelligent." It does not contain information about acceptance criteria, study design, or performance metrics. The document is a clearance letter and an "Indications For Use" statement.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1