Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008774899

FEI Number

3008774899

Entity Name

Kiyou Jochugiku

City/State/Country

Kainan Wakayama, JP

Establishment Address

1135 Shimotsu-cho Kami, Kainan Wakayama 649-0164, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Kiyoujochugiku Co., Ltd (Owner Number: 10036033)

Owner / Operator Contact Address

1135 Shimotsuchokami, Kainan, JP-30 649-0164, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

K-2001 Instant Cooling Ice Bag K-2129 Soft Ice Pillow K-2118 Cooling Gel Sheet K-2475 Ice Pillow Double-Sided Soft and Hard Jumbo size 800g X 2 K-2190 Hello Kitty Cooling Gel Sheet K-2240 Relax Leg Cooling Gel Sheets Sage & Mint K-2192 Hello Kitty Cooling Gel Sheet K-2193 Hello Kitty Cooling Gel Sheet K-2128 Mini Ice Pack5 pack K-2117 Cooling Gel Sheet K-2122 Cooling Gel Sheet K-2185 Hello Kitty Soft Ice Pillow K-2119 Cooling Gel Sheet K-2120 Cooling Gel Sheet K-2017 Ice Pack for Bottle K-2121 Cooling Gel Sheet K-2350 Cooling Gel Sheet wigh Cooling Capsules K-2003 Ice Pack 200g K-2241 Relax Leg Cooling Gel Sheets Rosemary K-2018 Soft Ice Pack 400g K-2191 Hello Kitty Cooling Gel Sheet 3675 Foot Sole Sheet Cool Type H-5009 Adhesive Hand Warmer mini S-602 Foot Sole Sheets Ginseng U-5009 Adhesive Hand Warmer mini U-5008 Adhesive Hand Warmer H-5008 Adhesive Nukupon Hand Warmer S-601 Foot Sole Sheets 2334 Foot Sole Sheets Germanium Dent Clear H-5007 Nukupon Hand Warmer mini U-5007 Nukupon mini U-5009 Adhesive Nukupon mini H-5009 Adhesive Hand Warmer mini H-5008 Adhesive Nukupon Hand Warmer U-5006 Nukupon H-5006 Nukupon Hand Warmer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMF	Unit, Chilling	Physical Medicine	Class 1	890.5940	2015-07-06
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2015-07-06
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2018-02-21
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2011-04-14

Official Correspondent

Mizuho Okubo

US Agent Details

Myrtle Harrigan Business: U.S.Jaclean, Inc. Email: mharrigan@usjaclean.com Phone: (310) 5382298

Related Public Records

Same Entity

Kiyoujochugiku 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

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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3033273241	TRYPTECH SERVICES	Greensboro, NC, US
3009273990	NOVETEC GROUP LTD.	Kowloon, HK
3009134624	CSafe Global	Dayton, OH, US
3015527848	WEG Surgical Solutions	Greensboro, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008774899. Last updated year: 2026. Please use registration number 3008774899 when referencing this establishment in official correspondence.