Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010805941

FEI Number

3010805941

Entity Name

BIO PROTECH YANTAI INC

City/State/Country

Yantai Shandong, CN

Establishment Address

50 - 9, Beijingzhong Road, Development Zone, Yantai Shandong 264000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIO PROTECH, INC. (Owner Number: 9048345)

Owner / Operator Contact Address

151-3, Donghwagongdan-ro, Munmak-eup, Wonju-si, KR-42 26365, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042301

PMA Number

N/A

All Registered Proprietary Names

MAXIF Ultima5 CABLE, ELECTRODE PROEMG MAXEMS PROPENCIL PROPENCIL PROPLATE MAXTENS PROTENS EvaQMax Laparo TELECTRODE PROTENS Soft-Touch PROTAB PROEMG PROEEG PROTENS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2010-12-27
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2011-12-02
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2011-06-23
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2016-06-07
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2016-06-07
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-08-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-22
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-02-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2011-09-27
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2020-01-27
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2009-01-13
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2012-07-25
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2007-12-04
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2016-03-24
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-04

Official Correspondent

Namhyun Cho

US Agent Details

Ikro Park Business: BIO PROTECH USA INC. Email: nice@protechsite.com Phone: (909) 4641464

Related Public Records

Same Entity

BIO PROTECH, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9710582	BIO PROTECH, INC.	Wonju-si Gangwon, KR

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
K152984	Bio Protech, Inc.	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	2016-06-03
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3004558433	BIOWAVE CORPORATION	NORWALK, CT, US
3014315574	BRH MEDICAL LTD	Jerusalem, IL
9615033	FUJI DYNAMICS LIMITED	Dongguan Guangdong, CN
3004049909	EASYMED INSTRUMENTS CO., LTD.	Daliang, Shunde, Foshan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010805941. Last updated year: 2026. Please use registration number 3010805941 when referencing this establishment in official correspondence.