LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011433
    Device Name
    BALLERT CRANIAL MOLDING HELMET
    Manufacturer
    GEMA, INC.
    Date Cleared
    2001-06-12

    (33 days)

    Product Code
    MVA
    Regulation Number
    882.5970
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ballert Cranial Molding Helmet is intended for use by or under the direction of a physician for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-and brachycephalic-shaped heads.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Ballert Cranial Molding Helmet." This type of document does not contain the information requested regarding acceptance criteria, study details, and performance metrics because it is a clearance letter, not a study report or a technical datasheet.

    A 510(k) clearance letter indicates that the FDA has determined a new device is "substantially equivalent" to a legally marketed predicate device. This determination is based on the manufacturer's submission which includes information like intended use, technological characteristics, and safety and effectiveness data, but the letter itself does not detail the specific performance study results.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1