AXENA HEALTH, INC.

FDA Device Registration & Listing · Auburndale, MA, US · Registration 3026585193

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026585193
FEI Number
3026585193
Entity Name
AXENA HEALTH, INC.
City/State/Country
Auburndale, MA, US
Establishment Address
2120 Commonwealth Ave, Suite 1, Auburndale, MA 02466, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Axena Health, Inc. (Owner Number: 10087350)
Owner / Operator Contact Address
2120 Commonwealth Ave, Auburndale, MA 02466, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213913
PMA Number
N/A

All Registered Proprietary Names

Leva® Pelvic Health System Leva System Leva Pelvic Digital Health System Leva Pelvic Health System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIR Perineometer Obstetrics/Gynecology Class 2 884.1425 2023-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axena Health, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026585193. Last updated year: 2026. Please use registration number 3026585193 when referencing this establishment in official correspondence.
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