Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010400996

FEI Number

3010400996

Entity Name

R&L CO., LTD

City/State/Country

Gwangmyeong Gyeonggi, KR

Establishment Address

108, Haan-Ro, Gwangmyeong Gyeonggi 14319, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

R&L CO., LTD (Owner Number: 10046888)

Owner / Operator Contact Address

108, Haan-Ro, Gwangmyeong, KR-41 14319, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORGONE BIOMAT PROFESSIONAL(Alternate) ORGONE BIOMAT QUEEN(Alternate) ORGONE BIOMAT SINGLE(Alternate) BIOMAT KING(Alternate) BIOMAT MINI BIOMAT QUEEN(Basic) BIO-BELT BIOMAT PROFESSIONAL(Basic) ORGONE BIOMAT KING(Alternate) BIOMAT SINGLE(Alternate) Orgone Biomat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2017-04-19
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2014-05-27

Official Correspondent

No official correspondent registered.

US Agent Details

Kralium Um Business: Onbix Corp US Email: onbixUS@gmail.com Phone: (843) 5828036

Related Public Records

Same Entity

R&L 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

Registration Number	Establishment Name	Location
3014113673	DONGGUAN XINJIN THERMO CONTROL MANUFACTURING CO., LTD.	DONGGUAN CITY Guangdong, CN
3042277608	LIAONING DIKANGYUAN HEALTH TECHNOLOGY CO.,LTD.	LIAOYANG Liaoning, CN
3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
3014290933	Wuhu OWFine Electronic Technology Co., Ltd.	Wuhu Anhui, CN
3026312365	BEIJING ETERNAL MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010400996. Last updated year: 2026. Please use registration number 3010400996 when referencing this establishment in official correspondence.