LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K193460
    Device Name
    The iNAP One Sleep Therapy System
    Manufacturer
    Somnice, Inc.
    Date Cleared
    2020-05-26

    (162 days)

    Product Code
    OZR
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Somnice, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.
    Device Description
    The iNAP One Sleep Therapy System consists of six (6) main components. The components are a console, a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), a soft polymer oral interface (iNAP Oral Interface) and a software application for mobile devices (iNAP Care). One additional accessory is Oral Interface with Tubing, which is a combination of the Oral Interface and Tubing Set. The function of iNAP One Sleep Therapy System is developing a negative pressure gradient in the user's oral cavity, which is set as -40 mmHg.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1