Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006622779

FEI Number

3006622779

Entity Name

KARIS CO., LTD.

City/State/Country

Gimpo-si Gyeonggi, KR

Establishment Address

23-19 Wolha-ro, 671 beon-gil, Haseong-myeon, Gimpo-si Gyeonggi 415-887, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KARIS Co., Ltd. (Owner Number: 10046700)

Owner / Operator Contact Address

23-19 Wolha-ro, 671 beon-gil, Haseong-myeon, Gimpo-si, KR-41 10011, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Relief Pak 12 pack heating Unit or Relief Pak 12 pack heating Unit mobile (Model: 11-1985) Moist Hot-Pack Unit (Models: KRS-4P-A2D32, KRS-6P-A2D32, KRS-8P-A2D32, KRS-12P-A2D32, KRS-24P-A2D32) Moist Hot-Pack Unit (Models: KRS-4P-A1A31) Moist Hot-Pack Unit (Models: KRS-4PAFD(MET), KRS-6PAFD(MET), KRS-8PAFD(MET), KRS-12PAFD(MET), KRS-24PAFD(MET)) Moist Hot-Pack Unit (Models: KRS-4P-A1D31, KRS-4P-A1D32, KRS-6P-A1D32, KRS-8P-A1D32, KRS-12P-A1D32, KRS-24P-A1D32) Relief Pak 6 pack heating Unit or Relief Pak 6 pack heating Unit stationary (Model: 11-1982) Moist Hot-Pack Unit (Models: KRS-4PAFA(MET), KRS-6PAFA(MET), KRS-8PAFA(MET), KRS-12PAFA(MET), KRS-24PAFA(MET)) Relief Pak 8 pack heating Unit or Relief Pak 8 pack heating Unit mobile (Model: 11-1984) Relief Pak 4 pack heating Unit or Relief Pak 4 pack heating Unit stationary (Model: 11-1981) Relief Pak 24 pack heating Unit or Relief Pak 24 pack heating Unit mobile (Model: 11-1986) Moist Hot-Pack Unit (Models: KRS-4P-D2D32, KRS-6P- D2D32, KRS-8P- D2D32, KRS-12P- D2D32, KRS-24P- D2D32) Relief Pak 4 pack heating Unit stationary (Model: 11-1980) Moist Hot-Pack Unit (Models: KRS-4PUF, KRS-6PUF, KRS-8PUF, KRS-12PUF, KRS-24PUF) Moist Hot-Pack Unit (Models: KRS-6P-A1A32, KRS-8P-A1A32, KRS-12P-A1A32, KRS-24P-A1A32) Moist Hot-Pack Unit (Models: KRS-4PUB, KRS-6PUB, KRS-8PUB, KRS-12PUB, KRS-24PUB)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRQ	Unit, Heating, Powered	Physical Medicine	Class 1	890.5950	2014-04-30

Official Correspondent

Hak Yong Lee

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

KARIS Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3017265430	SHENZHEN YOUMAY ELECTRONICS CO., LTD	Shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006622779. Last updated year: 2026. Please use registration number 3006622779 when referencing this establishment in official correspondence.