Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017435733

FEI Number

3017435733

Entity Name

SHANGHAI GK INDUSTRIAL CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

Rm1602, Area C, 1 floor, No.9565 Huqingping Rd. Qingpu District, Shanghai 201718, CN

Establishment Type(s)

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

Owner / Operator

Shanghai GK Industrial Co.,Ltd. (Owner Number: 10076656)

Owner / Operator Contact Address

Rm1602, Area C, 1 floor, No.9565 Huqingping Rd. Qingpu District, Shanghai, CN-SH 201718, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Knee brace heating pad Eye heating pad Heated Ankle Brace Body Heating pad Heated eye mask Body massager, knee massager, back massager Warming neck and shoulder wrap Warming eye mask Warming body wrap Red light therapy body pad, Red light therapy knee wrap, Red light back support

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	2020-07-26
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-07-26
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-09-01
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2020-07-26
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-09-01

Official Correspondent

Jango Wang

US Agent Details

Hong Hui Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Shanghai GK Industrial 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 3017435733. Last updated year: 2026. Please use registration number 3017435733 when referencing this establishment in official correspondence.