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NEUROMETRIX, INC.

USA · Woburn

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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

3listed device types

Class I 0Class II 3Class III 0

plus 3 registration records and 18 510(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

3active device licences

Class II 3

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States3 registration records, 18 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: NEUROMETRIX, INC.

FDA 510(k) clearances by year

11998

12000

12001

12002

12004

12006

22008

32009

22012

12013

22014

12016

12022

FDA listed device types

Electrode, Cutaneous 1Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN210046	Quell-FM	2022-05-18
US	K152954	Quell	2016-01-05
US	K140586	ASCEND ELECTRODE	2014-11-17
CA	77349	ADVANCE NERVE CONDUCTION/ELECTROMYOGRAPHY SYSTEM	Class II
CA	91723	SENSUS	Class II
CA	96003	QUELL	Class II

NEUROMETRIX, 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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