Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013077196

FEI Number

3013077196

Entity Name

ASTEK TECHNOLOGY LTD.

City/State/Country

Tainan, TW

Establishment Address

No.118, Taizih Rd. Rende Hsiang, Tainan Hsien, Tainan 717, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

ASTEK Technology Ltd. (Owner Number: 10061317)

Owner / Operator Contact Address

No.118, Taizih Rd. Rende Hsiang, Tainan Hsien, Tainan, TW-TNN 717, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TENS and EMS Stimulator AK3-50 TENS Stimulator AK-10M TENS and EMS Stimulator AK3-25 TENS and EMS Stimulator AK3-20 EPG050050;EPG053083;EPL050050;EPL073150;EPP050050;EPP118058;EPP048000 AK100B;AK100C;AK100D;AK101;AK101B;AK101C;AK101D;AK350AIFT;EPB047047;EPB047098;EPD090147;EPD105203;EPG046046; AK360;AK368;AK370;AK660;AK770;AK880;AK10MA;AK325A;AK320A;AK350A;AK500;AK510;AK520;KR1300;KR1600;AK100;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2020-02-11
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2020-02-11
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-10-07

Official Correspondent

You-Jhe Lin

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

ASTEK Technology 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
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

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3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013077196. Last updated year: 2026. Please use registration number 3013077196 when referencing this establishment in official correspondence.