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Bio Protech Yantai Inc: FDA-registered device maker in Yantai Shandong, China, 19 510(k) clearances

Name: Bio Protech Yantai Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bio Protech Yantai Inc is registered with the FDA (registration 3010805941) in Yantai Shandong, China. It lists 12 device types. The FDA files 19 510(k) clearances under its listings, the newest dated August 29, 2019. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010805941
Address: 50 - 9, Beijingzhong Road Development Zone, Yantai Shandong, China, 264000
Owner or operator: BIO PROTECH, INC. (9048345)
Roles: Manufacturer
First device listed: December 4, 2007
Registered through: 2027
Brand names listed: CABLE, ELECTRODE, EvaQMax, EvaQMax Laparo, MAXEMS, MAXIF, MAXTENS, PROEEG, PROEMG and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Exhaust, Surgical	FYD	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Electrode, Needle	GXZ	2	Manufacturer	accessdata.fda.gov
Electrode, Needle, Diagnostic Electromyograph	IKT	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Manufacturer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 29, 2019	K192035	EvaQMax Smoke Evacuation System	FYD	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
June 3, 2016	K152984	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	IKT	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
March 21, 2016	K153019	Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes	GXY	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
July 16, 2015	K143103	PROPENCIL Smoke Pencil	GEI	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
November 17, 2014	K142099	CUTANEOUS ELECTRODES	GXY	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
September 13, 2011	K111270	REUSABLE STIMULATING ELECTRODES	GXY	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
November 24, 2010	K100246	MAX-IF1000	LIH	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
November 30, 2009	K091248	MAXEMS, MODELS 1000 AND 2000	IPF	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
November 25, 2009	K092732	PROPENCIL ESU PENCIL	GEI	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
November 24, 2009	K092761	PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C	GEI	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
January 6, 2009	K083494	ULTIMA FIVE	GZJ	Substantially Equivalent	Pain Management Technologies	accessdata.fda.gov
November 7, 2008	K083148	TELECTRODE WET GEL ECG ELECTRODE	DRX	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
February 7, 2008	K073438	PROSTIM 1000/2000	GZJ	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
December 19, 2007	K073360	PROPLATE	GEI	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
December 14, 2005	K053011	PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20	DRX	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
September 3, 2004	K042301	PROTENS ELECTRODE	GXY	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
April 7, 2004	K040784	PROTAB ECG TABB ELECTRODE	DRX	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov
May 5, 2003	K030375	SOFT-TOUCH TENS ELECTRODE	GXY	Substantially Equivalent	Pain Management Technologies	accessdata.fda.gov
November 7, 2002	K020003	ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE	DRX	Substantially Equivalent	Bio Protech, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 29, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.