The following data is part of a premarket notification filed by The Snore Reliever Company, Llc with the FDA for Vital Sleep.
| Device ID | K201719 |
| 510k Number | K201719 |
| Device Name: | Vital Sleep |
| Classification | Device, Anti-snoring |
| Applicant | The Snore Reliever Company, LLC 4201 Tonnelle Avenue; Unit 202 North Bergen, NJ 07047 |
| Contact | David Hernandez |
| Correspondent | Christopher J. Devine Devine Guidance International, Inc. 4730 South Fort Apache Road; Suite 300 Las Vegas, NV 89147 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2021-01-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITAL SLEEP 85760282 not registered Dead/Abandoned |
Healthy Directions, LLC 2012-10-22 |
![]() VITAL SLEEP 77792613 3890953 Live/Registered |
The Snore Reliever Company LLC 2009-07-29 |