Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710582

FEI Number

3003514332

Entity Name

BIO PROTECH, INC.

City/State/Country

Wonju-si Gangwon, KR

Establishment Address

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

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

K053011

PMA Number

N/A

All Registered Proprietary Names

Smoke Evacuation Tubing EvaQMax Laparo TELECTRODE PROTENS Soft-Touch MAXEMS PROTENS MAXTENS PROTENS EvaQMax EvaQMax Laparo MAXIF Ultima5 CABLE, ELECTRODE PROTENS PROPLATE PROEMG PROEEG PROEMG PRONEO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-03-21
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2007-12-04
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2012-07-25
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-12-18
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-01-25
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
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2019-08-30
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2020-01-27
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
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2016-03-24
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
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	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
3010805941	BIO PROTECH YANTAI INC	Yantai Shandong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710582. Last updated year: 2026. Please use registration number 9710582 when referencing this establishment in official correspondence.