Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012729332

FEI Number

3012729332

Entity Name

GUANGZHOU HUAKAI ELECTRONIC TECHNOLOGY CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

4th Floor, Building 8, Bigang Ind Zone, Nangang,Huangpu District, Guangzhou Guangdong 510730, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou HuaKai Electronic Technology Co., Ltd. (Owner Number: 10050595)

Owner / Operator Contact Address

4th Floor, Building 8, Bigang Ind Zone, Nangang,Huangpu District, Guangzhou, CN-GD 510730, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Foot Massager, Huakai Foot Massager, HK-805H, HK-802H, HK-803A, HK-805B, HK-807, HK-818, HK-809, HK-802FS, HK-805C, HK-803, HK-805D, HK-805A, 807D, 803B, HK-710A, HK-710B, HK-710C, HK-710D, HK-801A, HK-801B, HK-801M, HK-712 HK-807D, HK-802Pro, HK-712P, HK-730

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2015-12-07
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2017-10-26

Official Correspondent

Anna Wu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Guangzhou HuaKai Electronic Technology Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

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3016460723	ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD.	Lishui Zhejiang, CN
3032903908	TECHDERM LLC	Palm Beach Gardens, FL, US
3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012729332. Last updated year: 2026. Please use registration number 3012729332 when referencing this establishment in official correspondence.