Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020956494

FEI Number

3020956494

Entity Name

PELVANA HEALTH, LLC

City/State/Country

Fort Worth, TX, US

Establishment Address

5970 Park Vista Cir Ste 124, Fort Worth, TX 76244, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Pelvana Health, LLC (Owner Number: 10084273)

Owner / Operator Contact Address

5970 Park Vista Circle, Suite 124, Fort Worth, TX 76244, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pelvana 30 Vaginal Applicators Pelvana Boric Acid Kit 30+7 Pelvana Boric Acid Kit 30+7+20 Pelvana Boric Acid Kit 60+15 Pelvana Boric Acid Kit 60+15+50 Pelvana 15 Vaginal Applicators Pelvana 60 LH Test Strips Pelvana 30 LH Test Strips Pelvana Boric Acid Kit 30+7+20 Pelvana Boric Acid Kit 60+15+50 Pelvana 50 Vaginal pH Test Strips Pelvana pH + UTI Combo Pack Pelvana 20 Vaginal pH Test Strips Pelvana 100 Vaginal pH Test Strips Pelvana 10 Vaginal pH Test Strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2024-12-23
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2025-12-19
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2025-12-19

Official Correspondent

Richard Elliott

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pelvana Health, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020956494. Last updated year: 2026. Please use registration number 3020956494 when referencing this establishment in official correspondence.