Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004839404

FEI Number

3004839404

Entity Name

AVAZZIA, INC.

City/State/Country

DALLAS, TX, US

Establishment Address

13140 Coit Rd Ste 515, DALLAS, TX 75240, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AVAZZIA, INC. (Owner Number: 9067759)

Owner / Operator Contact Address

13140 COIT ROAD, STE. 515, --, Dallas, TX 75240, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062641

PMA Number

N/A

All Registered Proprietary Names

Pelvic MS and Pelvic Probes BEST-PRO1 Avazzia Lead Wire Avazzia Blue Med-Sport Med-Best Conductive wrap, conductive garment Biofeedback Microcurrent BEST-RSI Avazzia Blue AvazziaLife Best-Pro 1, Biomodulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2008-03-31
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2004-10-29
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2004-10-29
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2016-09-13
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2017-06-16
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-06-16
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2016-09-22
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2006-12-05
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-03-31

Official Correspondent

R Harman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AVAZZIA, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13

Similar Registrations

Registration Number	Establishment Name	Location
9616877	EVERYWAY MEDICAL INSTRUMENTS CO., LTD.	NEW TAIPEI CITY, TW
3006897018	Savantini Holdings Limited	Hull East Riding of Yorkshire, GB
3009466220	INCONTROL MEDICAL, LLC	Pewaukee, WI, US
3017448360	LABORIE MEDICAL TECHNOLOGIES CORP.	Portsmouth, NH, US
3006850006	Well-Life Healthcare Limited	Jhonghe Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004839404. Last updated year: 2026. Please use registration number 3004839404 when referencing this establishment in official correspondence.