Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030358

FEI Number

3004261368

Entity Name

SATO PHARMACEUTICAL CO., LTD.

City/State/Country

MINATO-KU Tokyo, JP

Establishment Address

5-27, 1-CHOME, MOTOAKASAKA,, MINATO-KU Tokyo 107, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SATO PHARMACEUTICAL CO., LTD. (Owner Number: 8030358)

Owner / Operator Contact Address

Hillcrest 373 Bldg., 2F,, 1-7-8, Motoakasaka, Minato-ku, JP-13 107-0051, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stona Cooling Gel Pad Acess Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2013-05-22
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2005-07-28

Official Correspondent

Tamami Mito

US Agent Details

Paulette Flora Business: R. FLORA & ASSOCIATES, INC. Email: pflora@rflora.com Phone: (949) 4707970

Related Public Records

Same Entity

SATO PHARMACEUTICAL 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
2082295	SATO PHARMACEUTICAL, INC.	TORRANCE, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030358. Last updated year: 2026. Please use registration number 8030358 when referencing this establishment in official correspondence.