Data / Medical devices / United States / Embrace Healthcare LLC
Embrace Healthcare LLC: FDA-registered device maker in Nashua, NH, United States, 1 510(k) clearance
Embrace Healthcare LLC is registered with the FDA (registration 3002680644) in Nashua, NH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 19, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002680644
- Address
- 100 Factory Street Suite C3, Nashua, NH, United States, 03060
- Owner or operator
- Embrace Healthcare LLC (10023625)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- EYE SHIELDS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 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 |
|---|---|---|---|---|---|---|
| July 19, 1994 | K941932 | SPLASH MASK | LYU | Substantially Equivalent | Incon Diversified Industries, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 19, 1994. 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.