The following data is part of a premarket notification filed by Sleeping Well, Llc with the FDA for Zquiet Advance.
| Device ID | K213088 |
| 510k Number | K213088 |
| Device Name: | ZQuiet Advance |
| Classification | Device, Anti-snoring |
| Applicant | Sleeping Well, LLC 138 Steeplebush Rd. Shelburne, VT 05482 |
| Contact | Daniel Webster |
| Correspondent | William McLain Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-24 |
| Decision Date | 2022-06-15 |