Identifiers
- 510(k) Number
- K160239 FDA 510(k)
- FDA Product Code
- PLC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TAP 3 and TAP 1 are sleep appliances with patient monitoring designed for the treatment of sleep disordered breathing. These devices function as oral appliances to address conditions ranging from simple snoring to obstructive sleep apnea.
These devices are authorized under FDA 510k clearance. They are custom-fabricated oral appliances that utilize a hook-and-socket mechanism for mandibular advancement.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TAP 3 - TAP Sleep Care - Airway Management, Airway Management TAP 3 TL - MedGrade, TAP Products - TAP Sleep Care - Airway Management, TAP Airway Management - sleepapnealancaster.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160239 | Class II | Active |
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Manufacturer
- Manufacturer
- Airway Management Inc
- FDA Applicant
- Airway Management, Inc.
Sources (1)
- FDA 510(k) K160239 24 fields · synced Sep 22, 2026