Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2245302

FEI Number

2245302

Entity Name

NEUROTRON MEDICAL

City/State/Country

Warminster, PA, US

Establishment Address

1520 Campus Drive, Unit K, Warminster, PA 18974, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEUROTRON MEDICAL dba NEUMED (Owner Number: 9035553)

Owner / Operator Contact Address

1520 Campus Drive, Unit K, Warminster, PA 18974, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

THERAKNIT ORTHOFECT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2015-12-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2006-12-13
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2008-12-22

Official Correspondent

JACK GULDALIAN, JR.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEUROTRON MEDICAL dba NEUMED

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
1055808	PRIZM MEDICAL, INC.	Buford, GA, US
1650946	COMPUMEDICS USA, INC.	Charlotte, NC, US
3007481893	Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center	Fukaya-Shi Saitama, JP
1000524645	NORTHWEST COSMETIC LABS, LLC d/b/a Elevation Labs Idaho	Idaho Falls, ID, US
3004146401	GEMORE TECHNOLOGY CO., LTD.	TAN SHUI New Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245302. Last updated year: 2026. Please use registration number 2245302 when referencing this establishment in official correspondence.