Data / Medical devices / United States / Remsleep Holdings Inc
Remsleep Holdings Inc: FDA-registered device maker in Blackshear, GA, United States, 2 510(k) clearances
Remsleep Holdings Inc is registered with the FDA (registration 3022159083) in Blackshear, GA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 7, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3022159083
- Address
- 3222 Hwy 84 Suite 101, Blackshear, GA, United States, 31516
- Owner or operator
- Remsleep Holdings Inc (10084751)
- Roles
- Specification developer
- First device listed
- April 10, 2025
- Registered through
- 2026
- Brand names listed
- DELTAWAVE Nasal Pillows System, DeltaWave Nasal Pillow System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 7, 2026 | K253939 | DeltaWave Nasal Pillow System | BZD | Substantially Equivalent | RemSleep Holdings, Inc. | accessdata.fda.gov |
| July 2, 2024 | K233415 | DELTAWAVE Nasal Pillows System | BZD | Substantially Equivalent | Remsleep Holdings | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.