Identity
- Trade Name
- flexTAP FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- TAP-FLEX-100 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851085006209 FDA UDI
- 510(k) Number
- K061732 FDA UDI
- FDA Product Code
- LRK FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
flexTAP by Airway Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
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- EMA — The Myerson Company Limited · Class II
- TAP 1 & 3 — Ortho Solutions LC · Class II
- EMA — The Myerson Company Limited · Class II
- SomnoDent ALPHA — SOMNOMED INC. · Class II
Cleared under the same submission
K061732 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Airway Technologies, Llc
Sources (1)
- FDA UDI d2b318ce-08a4-48fc-be8b-a77793497fed 35 fields · synced May 30, 2026