Data / Medical devices / United States / Elidah
Elidah: FDA-registered device maker in Newtown, CT, United States, 3 510(k) clearances
Elidah is registered with the FDA (registration 3014915464) in Newtown, CT, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014915464
- Address
- 31 Pecks Ln Ste 11, Newtown, CT, United States, 06470
- Owner or operator
- Elidah (10059852)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 28, 2019
- Registered through
- 2026
- Brand names listed
- BetterSleep Compression Socks, ELITONE URGE, Elitone, Elitone for Men
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cutaneous Electrode Stimulator For Urinary Incontinence | QAJ | 2 | Manufacturer | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | 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 23, 2026 | K253285 | Elitone for Men | QAJ | Substantially Equivalent | Elidah, Inc. | accessdata.fda.gov |
| February 24, 2023 | K223884 | ELITONE Urge Urinary Incontinence Device | QAJ | Substantially Equivalent | Elidah, Inc. | accessdata.fda.gov |
| February 11, 2019 | K183585 | Elitone Device | QAJ | Substantially Equivalent | Elidah, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 23, 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.