LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K182163
    Device Name
    Shear Stress Therapeutics SST 3000
    Manufacturer
    Shear Stress Therapeutics, LLC
    Date Cleared
    2019-07-09

    (333 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

    The Shear Stress Therapeutics SST 3000 can be used for the standard purposes of muscle stimulators:

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

    Not Found

    AI/ML Overview

    The provided text is a clearance letter from the FDA for a medical device called "Shear Stress Therapeutics SST 3000," a Powered Muscle Stimulator. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The letter focuses on the FDA's determination of substantial equivalence (510(k) clearance) to legally marketed predicate devices, the regulatory classification, and general controls provisions. It also includes the "Indications for Use" for the device, which are standard for muscle stimulators.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1