Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042193295

FEI Number

3042193295

Entity Name

JSO TECHNOLOGY SDN.BHD.

City/State/Country

KUALA LANGAT Selangor, MY

Establishment Address

NO.6, JALAN RAJAWALI 17,KAWASAN PERUSAHAAN KEBUN BARU,BATU 9, TELOK PANGLIMA GARANG, KUALA LANGAT Selangor 42500, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JSO TECHNOLOGY SDN.BHD. (Owner Number: 10094381)

Owner / Operator Contact Address

NO.6, JALAN RAJAWALI 17,KAWASAN PERUSAHAAN KEBUN BARU,BATU 9, TELOK PANGLIMA GARANG, KUALA LANGAT, MY-10 42500, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Insect Bite Healers(JCA-SB1316) Insect Bite Healers(JSO-1335) Insect Bite Healers(JSO-1316)

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	2025-11-26

Official Correspondent

Lionel Xu

US Agent Details

Nelson Xie Business: WISELINK MEDICAL INC. Email: nelson.xie@wiselinkus.com Phone: (631) 2558110

Related Public Records

Same Entity

JSO TECHNOLOGY SDN.BHD.

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
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042193295. Last updated year: 2026. Please use registration number 3042193295 when referencing this establishment in official correspondence.