Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020648

FEI Number

2020648

Entity Name

ELECTROMEDICAL PRODUCTS INTL., INC.

City/State/Country

Mineral Wells, TX, US

Establishment Address

2201 GARRETT MORRIS PKWY., Mineral Wells, TX 76067, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

ELECTROMEDICAL PRODUCTS INTL., INC. (Owner Number: 9027065)

Owner / Operator Contact Address

2201 GARRETT MORRIS PKWY., --, Mineral Wells, TX 76067, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K896948

PMA Number

N/A

All Registered Proprietary Names

Alpha-Stim M, Trudenta Alpha-Stim M,Alpha-Stim 100, Alpha-Stim SCS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-11-29

Official Correspondent

Brian Burke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELECTROMEDICAL PRODUCTS INTL., 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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020648. Last updated year: 2026. Please use registration number 2020648 when referencing this establishment in official correspondence.