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510(k) Data Aggregation

    K Number
    K974070
    Device Name
    PHYSIO/1000
    Manufacturer
    PHYSIO DESIGNS, INC.
    Date Cleared
    1998-01-06

    (70 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHYSIO DESIGNS, INC.

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

    The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.

    Device Description

    Physio / 1000 Alternating Pressure Mattress System

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Physio/1000 Alternating Pressure Mattress System." It primarily addresses the regulatory approval process and does not contain detailed information on acceptance criteria or the specific studies used to demonstrate device performance.

    Therefore, I cannot provide the requested information based on the provided text. The document states that the device is "substantially equivalent" to predicate devices, but it does not elaborate on the specific performance data or studies that established this equivalence.

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