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Lead-Lok, Inc.

USA · Sandpoint

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 0Class II 8Class III 0

plus 11 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 5 510(k), 0 PMA, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: LEAD-LOK, INC. d.b.a Nissha Medical Technologies · LEAD-LOK INC

FDA 510(k) clearances by year

11989 · K895100

11990 · K903729

21992 · K911529

12001 · K010431

FDA listed device types

Detector And Alarm, Arrhythmia 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Reduced- Montage Standard Electroencephalograph 1Amplitude-Integrated Electroencephalograph 1Stimulator, Nerve 1Neurosurgical Nerve Locator 1Computer, Diagnostic, Programmable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K010431	LEAD-LOK REUSABLE TENS/ NMES ELECTRODES	2001-09-06
US	K911529	BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG	1992-11-09
US	K911518	BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM	1992-11-09

Lead-Lok, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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