Identifiers
- 510(k) Number
- K061732 FDA 510(k)
- FDA Product Code
- LRK 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-T is a device classified as an anti-snoring device under FDA 510(k) clearance K061732. It is substantially equivalent to a predicate device and falls under the dental advisory committee classification.
The device is manufactured by Airway Management Inc. and is authorized for marketing in the United States. It is a Class II medical device regulated under FDA regulation number 872.5570.
Frequently asked questions
What is the TAP-T device used for?
The TAP-T is classified as an anti-snoring device, designed to reduce or prevent snoring by maintaining airway patency during sleep, based on its FDA 510(k) submission and dental advisory committee classification.
Who manufactures the TAP-T and where are they located?
The TAP-T is manufactured by Airway Management Inc., located at 6116 N. Central Expy., Suite 605, Dallas, TX 75206, United States, as stated in the device authorization records.
What regulatory pathway was used for the TAP-T's market authorization?
The TAP-T received market authorization through the FDA 510(k) pathway under clearance number K061732, demonstrating substantial equivalence to a legally marketed predicate device.
What is the device classification and regulation number for the TAP-T?
The TAP-T is a Class II medical device regulated under FDA regulation number 872.5570, with product code LRK, and falls under the dental medical specialty as per its FDA submission.
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: Airway Management - Home - TAP Sleep Care, TAP Products - TAP Sleep Care - Airway Management, TAP Sleep Care | Airway Management, Inc. - LinkedIn, 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 | K061732 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Airway Management Inc
- FDA Applicant
- Airway Management, Inc.
Sources (1)
- FDA 510(k) K061732 24 fields · synced Sep 27, 2026