Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008485370

FEI Number

3008485370

Entity Name

Zhongshan Transtek Electronics Co., Ltd

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

Zone E, No. 105, Dongli Road, Torch Development District, Zhongshan Guangdong 528437, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong Transtek Medical Electronics Co., Ltd (Owner Number: 10032922)

Owner / Operator Contact Address

Zone A, No.105 ,Dongli Road Torch Development District Zhongshan, Guangdong, Zhongshan, CN-GD 528437, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130311

PMA Number

N/A

All Registered Proprietary Names

GBF-2008-B1 EZFAST Body Fat Analyzer, GBF-2108-B GBF-2008-B3 Scale,Stand-on, Patient 1169-05 BS-2001-G1 GBS-2104-G digbi health Body Scale,Model:GBS-2012-B BT006 R.P.M. PRO Digital Weight Scale, Model:210-1113B gG Baby Scale 0222 TRANSTEK BODY ANALYZER MODEL GBF-1251-B, BF-1256, GBF-1319B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2024-01-30
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2017-11-30
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2012-09-17
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2024-12-26
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2013-06-08

Official Correspondent

Aimee Li

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Guangdong Transtek Medical Electronics 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
K994242	Bodystat , Ltd.	BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT	2000-03-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008485370. Last updated year: 2026. Please use registration number 3008485370 when referencing this establishment in official correspondence.