Data / Medical devices / United States / Good Sleep Co Usa LLC
Good Sleep Co Usa LLC: FDA-registered device maker in Grand Prairie, TX, United States, 2 510(k) clearances
Good Sleep Co Usa LLC is registered with the FDA (registration 3031282374) in Grand Prairie, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031282374
- Address
- 805 W Carrier Pkwy Ste 240, Grand Prairie, TX, United States, 75050
- Owner or operator
- Good Sleep Co Pte Ltd (10090836)
- Roles
- Manufacturer
- First device listed
- December 22, 2024
- Registered through
- 2026
- Brand names listed
- Avera, HUSHD PRO Z-LINK, Hushd Pro Avera, Hushd Pro Guard, Splint, Z-LINK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 24, 2025 | K251784 | Hushd Pro Z-Link | LRK | Substantially Equivalent | Good Sleep CO Pte , Ltd. | accessdata.fda.gov |
| May 9, 2024 | K232025 | Hushd Pro Avera | LRK | Substantially Equivalent | Good Sleep CO Pte , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 24, 2025. 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.