Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613446

FEI Number

1000533128

Entity Name

ITO CO., LTD.

City/State/Country

Kawaguchi Saitama, JP

Establishment Address

3-1-8 Sakae-cho, Kawaguchi Saitama 332-0017, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ITO CO., LTD. (Owner Number: 9003170)

Owner / Operator Contact Address

3-1-8 Sakae-cho, Kawaguchi, JP-11 332-0017, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ES-130 TM-400 D function ES-160 Accu-Patch Gold Plated Type with Tan Color Tape Magrain Silver with Tan Color Tape, without pack, with Latex Accu-Patch Stainless steel Type with Tan Color Tape with Latex Accu-Patch Gold Plated Type with Clear Tape Accu-Patch Stainless steel Type with Clear Tape Magrain-5 Silver Type, without pack, with Latex Magrain Conical Pellets with Tan Color Tape, without pack Accu-Patch Titanium with Clear Tape Magrain-5 Silver Type, without pack Accu-Patch Stainless steel Type with Tan Color Tape Magrain Silver with Clear Tape, without pack Magrain Gold with Tan Color Tape, without pack Accu-Patch Gold Plated Type with Tan Color Tape with Latex Magrain Conical Pellets with Tan Color Tape, without pack, with Latex Magrain Gold with Clear Tape, without pack Accu-Patch Conical Pellets with Tan Color Tape, with Latex Magrain Silver with Tan Color Tape, without pack Magrain Gold with Tan Color Tape, without pack, with Latex Accu-Patch Conical Pellets with Tan Color Tape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2008-12-18
ITH	Equipment, Traction, Powered	Physical Medicine	Class 2	890.5900	2008-12-18
NUW	Stimulator, Muscle, Powered, Dental	Physical Medicine	Class 2	890.5850	2021-09-07
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-01-09
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2011-08-22

Official Correspondent

KENNETH BLOCK

US Agent Details

Kenneth Block Business: Ken Block Consulting Email: K.Block@Kenblockconsulting.Com Phone: (972) 4809554

Related Public Records

Same Entity

ITO CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614750	ITO CO., LTD. Tsukuba Factory	Inashiki-Gun Ibaraki, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13

Similar Registrations

Registration Number	Establishment Name	Location
3012184208	SPEEDY GREAT LIMITED	North Point, HK
2939821	NORTH COAST MEDICAL, INC.	Morgan Hill, CA, US
3010350335	Neurostimulation Medtech Private Limited	Chennai Tamil Nadu, IN
3007710601	WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD	Wuxi Jiangsu, CN
9614750	ITO CO., LTD. Tsukuba Factory	Inashiki-Gun Ibaraki, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613446. Last updated year: 2026. Please use registration number 9613446 when referencing this establishment in official correspondence.