Contract manufacturerELEMENTS SLEEP, LLC (Mesquite, TX)TexasGeneral hospitalClass I
ELEMENTS SLEEP, LLC
Contract manufacturer · Mesquite, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3035380696 (openFDA record; or search FDA's registration database)
- FEI number
- 3035380696
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Elements Sleep, LLC (FDA owner/operator no. 10092471)
- Registered address
- 1475 Republic Pkwy Ste 200, Mesquite, TX 75150
- Contract listings
- 1 device listings, 1 product codes, first listed Jan 10, 2025
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered | Class I | General hospital | Contract manufacturing | Jan 10, 2025 |