Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023164

FEI Number

3023164

Entity Name

LEAD-LOK, INC. d.b.a Nissha Medical Technologies

City/State/Country

Sandpoint, ID, US

Establishment Address

814 AIRPORT WAY, Sandpoint, ID 83864, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Nissha Medical Technologies (Owner Number: 9106359)

Owner / Operator Contact Address

400 EXCHANGE STREET, --, Buffalo, NY 14204, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Swaromed Z-Brand SofTouch SilveRest VersaTrode Lead-Lok BluFlex V-Series EMS Electrodes TenderTrode Plus PhysioFlow PNS Electrodes ClearScan Guardian Performance Plus TenderTrode Regal SimplySnap Preventice cardiac monitoring

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-06-28
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-01-21
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-08-23
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2018-08-23
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2012-12-07
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2015-01-16
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-12-05
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2015-12-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-07-27
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-06-14

Official Correspondent

Jessica Potter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nissha Medical Technologies

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008933393	Nissha Medical Technologies Limited	Paignton Devon, GB
1317188	Graphic Controls Acquisition Corp.dba Nissha Medical Technologies	BUFFALO, NY, US
3006891611	CEA Global Dominicana d.b.a. Nissha Medical Technologies	San Pedro de Macoris, DO
1721983	CEA Medical Manufacturing, Inc.	Colorado Springs, CO, US
1519132	Nissha Medical Technologies (Ohio), Inc.	Norwalk, OH, US

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

Registration Number	Establishment Name	Location
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3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023164. Last updated year: 2026. Please use registration number 3023164 when referencing this establishment in official correspondence.