Company ยท US
Sleeping Well, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2022. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LRK | Device, Anti-Snoring | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2022 | K213088 | ZQuiet Advance Sleeping Well, LLC | LRK |
| Jun 12, 2018 | K180124 | ZQuiet Sleeping Well, LLC | LRK |
| Jul 25, 2014 | K140777 | ZQUIET-SA Sleeping Well, LLC | LRK |
| Dec 7, 2012 | K122475 | ZQUIET PRO-PLUS Sleeping Well, LLC | LRK |
| Jun 22, 2010 | K093407 | ZQUIET MOUTHPIECE Sleeping Well, LLC | LRK |
| Mar 10, 2009 | K090503 | ZQUIET MOUTHPIECE Sleeping Well, LLC | LRK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||