Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614750

FEI Number

3004546558

Entity Name

ITO CO., LTD. Tsukuba Factory

City/State/Country

Inashiki-Gun Ibaraki, JP

Establishment Address

3-39-14 Uzurano, Ami-Machi, Inashiki-Gun Ibaraki 300-0341, JP

Establishment Type(s)

Manufacture Medical 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

K081247

PMA Number

N/A

All Registered Proprietary Names

D function ES-160 ES-130 TM-400

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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

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
9613446	ITO CO., LTD.	Kawaguchi Saitama, 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
9613446	ITO CO., LTD.	Kawaguchi Saitama, JP
3035374386	BTL Industries JSC	Plovdiv, BG
3014732	MYOTRONICS-NOROMED, INC.	KENT, WA, US
3007661914	AB ELECTRONICS	Danbury, CT, US
3037967280	ALGIAMED TECHNOLOGIES USA INC	Lake Mary, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614750. Last updated year: 2026. Please use registration number 9614750 when referencing this establishment in official correspondence.