Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616877

FEI Number

3002552319

Entity Name

EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

3 FL., NO. 5, LANE 155, SEC.3 BEISHEN RD., SHENKENG DIST., NEW TAIPEI CITY 22203, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EVERYWAY MEDICAL INSTRUMENTS CO., LTD. (Owner Number: 9043515)

Owner / Operator Contact Address

3 FL., NO. 5, LANE 155, SEC.3,, BEISHEN RD, SHENKENG DIST., NEW TAIPEI CITY, TW-TPE 22203, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202470

PMA Number

N/A

All Registered Proprietary Names

EV-820 EV-804 EV-804P PR-13A PR-14K PR-06K PR-04K PR-03 PR-13 PR-02 PR-06 PR-06A PR-03K PR-04 PR-03A PR-11A PR-10A PR-04A PR-02A PR-12A PR-14A ET-800 HC-888A HC-881A HC-893A HC-884A HC-882A HC-892A HC-889A HC-885A HC-883A HC-890A(PMT) EV-803 KF4060V KF5050 KF4040 KF75D KF50D KF4080 KF50100 KF50100V SKB5050 EV-820 EM-5200 CT100 (Over-door cervical traction) EverTrac CT800 (Cervical traction) N605 N607 N601-2A N601-2 E701 N601A N602 N602-1C N601 N602-1A N602-1B ET8007 (Chest garment) FS-2 (Bolster)420901 LT100 (Lumbar support) ET8008 (Lumbar garment) ET8002 (Head halter) EV-906A (Li-battery) ISTIM EV-805 (EVERYWAY4ALL) EV-906 (Li-battery) NMS-8021 (National Medical) PR-03A PR-04A PR-14A PR-02A EV-805I iSTIM PR-03 iSTIM PR-02A iSTIM PR-02-2 iSTIM PR-13A iSTIM PR-03A MT-200 N103A N302 N601L iSTIM PR-13A iSTIM PR-02-2 EM-5300 ISTIM EM-5200 (EVERYWAY4ALL) EM-5300 PR-03A (Probe) PR-04A (Probe) EM-2400 PR-14A (Probe) ISTIM V2 (EVERYWAY4ALL) EM-2400 PR-02A (Probe) KWELL EM1 (Intimd) DT-PROBE-V-3 DT-PROBE-V-1 DT-PROBE-A-1 DT-PROBE-A-2 iSTIM PR-03 iSTIM PR-03A DT-PROBE-V-2 iSTIM PR-02A EV-807P 20089(AXION USA)SG50100 SG75D SG5075 SG50100 SG60147 SG5795 SG4040 S55105 SG4368 SG5050 S80120 SG50D SG7090 20035(AXION USA)SG5050 EV-906A EV-906 EM-6200 EM-6000 EM-6200C EM-6100D EM-6100 EM-6300 EM-6300C EM-6100C PREMIER STIM PLUS (Boxout)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2011-11-09
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2018-04-20
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2013-04-11
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2013-04-11
ITH	Equipment, Traction, Powered	Physical Medicine	Class 2	890.5900	2012-02-15
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2011-09-01
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-11-17
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-11-17
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2015-11-02
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2018-09-27
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2018-09-27
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2012-01-18
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2007-11-17
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-11-17
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2018-08-03
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-10-25
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-10-25
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2017-10-18
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2015-06-08
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-12-23
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-11-17
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2021-12-06
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2007-11-17
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2018-04-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-09-24
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-09-24
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-11-25
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-11-25

Official Correspondent

No official correspondent registered.

US Agent Details

Alan P. Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616877. Last updated year: 2026. Please use registration number 9616877 when referencing this establishment in official correspondence.