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Data / Medical devices / United States / Liviwell Inc

Liviwell Inc: FDA-registered device maker in Mountain Lakes, NJ, United States, 1 510(k) clearance

Liviwell Inc is registered with the FDA (registration 3044091160) in Mountain Lakes, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 20, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3044091160
Address
333 Us Highway 46 Ste 201, Mountain Lakes, NJ, United States, 07046
Owner or operator
LiviWell Inc (10095514)
Roles
Complaint file establishment, Specification developer
First device listed
March 23, 2026
Registered through
2026
Brand names listed
Livi

Devices it lists

DeviceProduct codeClassRoleSource
Tampon, Menstrual, UnscentedHEB2Complaint file establishment, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 20, 2026K252005Livi DeviceHEBSubstantially EquivalentLiviwell, Inc.accessdata.fda.gov

Compare with other makers

Updated March 20, 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.