Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009862126

FEI Number

3009862126

Entity Name

INTELLIGENT SYSTEMS CO LTD

City/State/Country

Nanto Toyama, JP

Establishment Address

6317-1 Umehara, Nanto Toyama 939-1716, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Intelligent Systems Co Ltd (Owner Number: 10045453)

Owner / Operator Contact Address

6317-1 Umehara, Nanto, JP-16 939-1716, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PARO Robots

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2013-11-18

Official Correspondent

Takanori Shibata

US Agent Details

Jing Yun Yang Business: PARO Robots US Email: sales@parorobots.com Phone: (847) 4539882

Related Public Records

Same Entity

Intelligent Systems 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
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009862126. Last updated year: 2026. Please use registration number 3009862126 when referencing this establishment in official correspondence.