# Sleeping Well, LLC

- Location (FDA's records): Shelburne, VT
- FDA decisions: 6 (2009–2022): 6 510(k) clearances
- Product codes: LRK (6)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tomed Dr. Toussaint GmbH: 2 (https://510kreport.com/company/tomed-dr-toussaint)
- Somnomed, Inc.: 1 (https://510kreport.com/company/somnomed)
- Sleep Science Partners, Inc.: 1 (https://510kreport.com/company/sleep-science-partners)

## Firms that cite its devices most
- QuietLab, LLC: 2 (https://510kreport.com/company/quietlab)
- Firma Ingemarsson: 1 (https://510kreport.com/company/firma-ingemarsson)
- Snorebandit, LLC: 1 (https://510kreport.com/company/snorebandit)
- Michael D Williams Dds PA: 1 (https://510kreport.com/company/michael-d-williams-dds-pa)
- The Snore Reliever Company, LLC: 1 (https://510kreport.com/company/snore-reliever)

## Its most-cited devices
- K180124: ZQuiet (2018), cited by 4
- K090503: Zquiet Mouthpiece (2009), cited by 3
- K093407: Zquiet Mouthpiece (2010), cited by 2
- K213088: ZQuiet Advance (2022), cited by 1

## Recent decisions
- K213088: ZQuiet Advance (Jun 15, 2022)
- K180124: ZQuiet (Jun 12, 2018)
- K140777: Zquiet-SA (Jul 25, 2014)
- K122475: Zquiet Pro-Plus (Dec 7, 2012)
- K093407: Zquiet Mouthpiece (Jun 22, 2010)
- K090503: Zquiet Mouthpiece (Mar 10, 2009)

Source page: https://510kreport.com/company/sleeping-well