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Electromedical Products, Inc.

USA · Hawthorne

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

2listed device types

Class I 0Class II 2Class III 0

plus 2 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

4active device licences

Class II 4

6 including historic records

TWTaiwanTFDA

pendingnot queried

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 States2 registration records, 5 510(k), 0 PMA, 4 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: ELECTROMEDICAL PRODUCTS INTL., INC. · ELECTROMEDICAL PRODUCTS INTERNATIONAL, INC.

FDA 510(k) clearances by year

21983 · K831145

11988 · K881753

11990 · K896948

11992 · K903014

FDA listed device types

Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K903014	ALPHA-STIM CS	1992-05-12
US	K896948	ALPHA-STIM CS	1990-02-23
US	K881753	ALPHA-STIM 350	1988-08-30
CA	61332	ALPHA-STIM	Class II
CA	61871	TREATMENT PROBE WITH FELT ELECTRODES	Class II
CA	61872	LEAD WIRES	Class II

Electromedical Products, 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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