Home / Companies / Sleeping Well, LLC

Sleeping Well, LLC

FDA Regulatory Profile

Sleeping Well, LLC has 0 FDA recalls, 2 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 4, 2015 · NAI
Latest 510(k)
Jun 15, 2022

Reviewing Sleeping Well, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Sleeping Well, LLC's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 4, 2015Shelburne, VTDevicesNo Action Indicated (NAI)3008797926
Dec 2, 2011Shelburne, VTDevicesNo Action Indicated (NAI)3008797926

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K213088ZQuiet AdvanceJun 15, 2022
K180124ZQuietJun 12, 2018
K140777ZQUIET-SAJul 25, 2014
K122475ZQUIET PRO-PLUSDec 7, 2012
K093407ZQUIET MOUTHPIECEJun 22, 2010
K090503ZQUIET MOUTHPIECEMar 10, 2009

FDA data resources