HOT & HOT CO., LTD.

FDA Device Registration & Listing · Namyangju-si Gyeonggi, KR · Registration 3013684902

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013684902
FEI Number
3013684902
Entity Name
HOT & HOT CO., LTD.
City/State/Country
Namyangju-si Gyeonggi, KR
Establishment Address
99, Gyeongbokdae-ro 212beon-gil, Jinjeop-eup, Namyangju-si Gyeonggi 12063, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hot & Hot Co., LTD. (Owner Number: 10055279)
Owner / Operator Contact Address
99, Gyeongbokdae-ro 212beon-gil, Jinjeop-eup, Namyangju-si, KR-41 12063, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HOT & HOT Hot Pack HOT&HOT All In One Mattress Protector

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 2017-06-29
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 2020-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

Krallum Uju Business: Onbix Corp US Email: onbixus@gmail.com Phone: (843) 5828036

Related Public Records

Same Entity

Hot & Hot 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013684902. Last updated year: 2026. Please use registration number 3013684902 when referencing this establishment in official correspondence.
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