Data / Medical devices / United States / Sleeping Well, LLC
Sleeping Well, LLC: FDA-registered device maker in Shelburne, VT, United States, 7 510(k) clearances
Sleeping Well, LLC is registered with the FDA (registration 3008797926) in Shelburne, VT, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008797926
- Address
- 138 Steeplebush Rd., Shelburne, VT, United States, 05482
- Owner or operator
- Sleeping Well, LLC (10034704)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 23, 2010
- Registered through
- 2026
- Brand names listed
- ZQuiet, ZQuiet Advance Anti-Snoring Mouthpiece, ZQuiet Breathe, ZQuiet Chin-UP, ZQuiet Clean, ZQuiet Pro-Flex, ZQuiet Pro-Plus, ZQuiet-S.A.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleanser, Denture, Over The Counter | EFT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Specification developer | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 15, 2022 | K213088 | ZQuiet Advance | LRK | Substantially Equivalent | Sleeping Well, LLC | accessdata.fda.gov |
| June 12, 2018 | K180124 | ZQuiet | LRK | Substantially Equivalent | Sleeping Well, LLC | accessdata.fda.gov |
| July 25, 2014 | K140777 | ZQUIET-SA | LRK | Substantially Equivalent | Sleeping Well, LLC | accessdata.fda.gov |
| December 7, 2012 | K122475 | ZQUIET PRO-PLUS | LRK | Substantially Equivalent | Sleeping Well, LLC | accessdata.fda.gov |
| June 22, 2010 | K093407 | ZQUIET MOUTHPIECE | LRK | Substantially Equivalent | Sleeping Well, LLC | accessdata.fda.gov |
| March 10, 2009 | K090503 | ZQUIET MOUTHPIECE | LRK | Substantially Equivalent | Sleeping Well, LLC | accessdata.fda.gov |
| September 10, 2004 | K040491 | CHIN-UP STRIP | LWF | Substantially Equivalent | Dale Miller, Inc. - the Chin-Up Company | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Cleanser, Denture, Over The Counter
- All makers of Dilator, Nasal
Updated June 15, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.