Identifiers
- 510(k) Number
- K190058 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)
PureSleep is an anti-snoring device intended for over-the-counter use. It is classified as a Class II medical device.
The device is supplied as a single-use item. It is not sterilized and is not intended for use in an MRI environment.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190058 | Class II | Active |
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Manufacturer
- Manufacturer
- Sleep Science Partners, Inc.
Sources (1)
- FDA 510(k) K190058 24 fields · synced Sep 23, 2026