Data / Medical devices / United States / Ema-Sleep Inc
Ema-Sleep Inc: FDA-registered device maker in Bastrop, TX, United States, 1 510(k) clearance
Ema-Sleep Inc is registered with the FDA (registration 3039643908) in Bastrop, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 3, 2024. 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
- 3039643908
- Address
- 101 Gaston Dr, Bastrop, TX, United States, 78602
- Owner or operator
- EMA-Sleep Inc (10093941)
- Roles
- Specification developer
- First device listed
- August 14, 2025
- Registered through
- 2026
- Brand names listed
- EMA 3D
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Specification developer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | K232735 | EMA 3D | LRK | Substantially Equivalent | Ema Sleep Incorporated | accessdata.fda.gov |
Compare with other makers
Updated May 3, 2024. 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.