Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013445676

FEI Number

3013445676

Entity Name

LEADING EDGE MFG. INC.

City/State/Country

Langley British Columbia, CA

Establishment Address

E104 - 19720 94A Avenue, Langley British Columbia V1M3B7, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Leading Edge Mfg. Inc. (Owner Number: 10095700)

Owner / Operator Contact Address

E104 - 19720 94A Avenue, Langley, CA-BC V1M3B7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K083250

PMA Number

N/A

All Registered Proprietary Names

Cable, electrode Electroanalgesic delivery system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2026-04-16
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2026-04-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2026-04-15
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2026-04-15

Official Correspondent

Jared Nelson

US Agent Details

Lilian Llull Business: Techlink International LLC Email: lilian@techlinkusa.net Phone: (305) 2066777

Related Public Records

Same Entity

Leading Edge Mfg. 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
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

Similar Registrations

Registration Number	Establishment Name	Location
3017528618	ATRILITY MEDICAL, INC.	Madison, WI, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3030387292	WISE S.p.A.	Cologno Monzese Lombardy, IT
3033919280	DONGGUAN GOOCHAIN TECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3017619000	SHENZHEN REDY-MED TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013445676. Last updated year: 2026. Please use registration number 3013445676 when referencing this establishment in official correspondence.