Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3041000312

FEI Number

3041000312

Entity Name

SYSTEC ENGINEERING, LLC

City/State/Country

Euless, TX, US

Establishment Address

1000 Pamela Dr, Euless, TX 76040, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Systec Engineering, LLC (Owner Number: 10094041)

Owner / Operator Contact Address

1000 Pamela Drive, Euless, TX 76040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neurolumen PN-1000

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	2025-09-26

Official Correspondent

Andrew Thompson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Systec Engineering, LLC

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 3041000312. Last updated year: 2026. Please use registration number 3041000312 when referencing this establishment in official correspondence.