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510(k) Data Aggregation
K Number
K220907Device Name
The iNAP One Sleep Therapy System
Manufacturer
Date Cleared
2023-06-16
(444 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Somnics 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 include a console (Model R07-A), a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), soft polymer oral interfaces (iNAP Oral Interface), a Muffler (Optional) and a software application for mobile devices (iNAP Lab+). One additional accessory set (102C) is included, which is a combination of the iNAP Oral Interface and iNAP Tubing Set. The function of iNAP One Sleep Therapy System (Console Model: R07-A) is to develop a negative pressure gradient in user's oral cavity which can be adjusted between -20 to -90 mmHg (-27 to -122 cmH2O) via the App (iNAP Lab+) to achieve or maintain proper vacuum pressure for users.
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K Number
K152660Device Name
HYPNOSPAD
Manufacturer
Date Cleared
2016-11-09
(419 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Somnics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
HypnosPad (HP01) is a home-use mouthpiece and indicated for the treatment of night-time snoring. It is suitable for mild to moderate obstructive sleep apnea (OSA) patients in adults. The accessories of HyponsPad are a storage box and a spatula. The device is made by thermoflexible and biocompatible material. The usage method of HyponsPad is custom fit after hot water bathing. The duration of HypnosPad is about 8-10 hours contacting in patient's oral cavity. The HyponsPad is intended for holding the mandible in a protruded position thus maintaining the airway open during sleep. The HypnosPad will be used the spatula help to operate the device during boil and bite process. The HypnosPad will be stored in the storage box.
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