The following data is part of a premarket notification filed by Shinrin-yoku Traders Llc with the FDA for Silentzpro 2.0.
| Device ID | K220688 |
| 510k Number | K220688 |
| Device Name: | SilentZPro 2.0 |
| Classification | Device, Anti-snoring |
| Applicant | Shinrin-Yoku Traders LLC 18450 SW Seiffert Rd Sherwood, OR 97140 |
| Contact | Ryan Bruss |
| Correspondent | Roy Zhang RGLM Consulting LLC 6915 225th St SW Mountlake Terrace, WA 98043 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-08 |
| Decision Date | 2022-12-02 |