FDA Device Establishments · JSON-LD · Markdown

AXENA HEALTH, INC.

FEI 3026585193 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number3026585193
Owner / OperatorAxena Health, Inc. (#10087350)
Address2120 Commonwealth Ave, Suite 1, Auburndale, MA, US
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)HIR
Regulation § (21 CFR)884.1425
Proprietary namesLeva Pelvic Digital Health System; Leva® Pelvic Health System; Leva System; Leva Pelvic Health System

External sources

Source: openFDA. Public-domain (CC0).