flexTAP

Basic Information

• Brand Name: flexTAP
• Primary DI: 00851085006209
• Version / Model: TAP-FLEX-100
• Company Name: AIRWAY TECHNOLOGIES, LLC
• Labeler DUNS: 963501148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-25
• Public Version: 1
• Public Version Date: 2023-06-02
• Public Version Status: New
• Public Device Record Key: d2b318ce-08a4-48fc-be8b-a77793497fed

Device Description

The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related breathing disorders including obstructive sleep apnea (OSA). The flexTAP™ is a custom-made oral device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). The flexTAP™ device consists of an Upper Tray that fits over the upper teeth and Lower Tray that fits over the lower teeth.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47526	Mandible-repositioning sleep-disordered breathing orthosis	A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851085006209	GS1

Premarket Submissions

Submission Number	Supplement Number
K061732	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 122 Degrees Fahrenheit