Data / Medical devices / United States / Gurin Products LLC

Gurin Products LLC: FDA-registered device maker in Tustin, CA, United States, 5 510(k) clearances

Name: Gurin Products LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gurin Products LLC is registered with the FDA (registration 3006793151) in Tustin, CA, United States. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 31, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006793151
Address: 2522 Chambers Rd Ste 100, Tustin, CA, United States, 92780
Owner or operator: Gurin Products, LLC (10031258)
Roles: Repackager or relabeler
First device listed: October 20, 2017
Registered through: 2027
Brand names listed: 2F3133, AccuraPulse AP-WBPM810, Adhesive Electodes, Electro Therapy Massager MV950, GO-410, GURIN, GURIN GO-410, JPD-500E and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	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
December 31, 2025	K253305	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)	NUH	Substantially Equivalent	Shenzhen Jiantuo Electronics Co., Ltd.	accessdata.fda.gov
August 11, 2016	K160138	Adhesive Electrodes	GXY	Substantially Equivalent	Gmdasz Manufacturing Co., Ltd.	accessdata.fda.gov
October 3, 2013	K130947	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov
October 22, 2012	K122482	TRANSTEK WRIST BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
October 28, 2009	K092245	ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100	DXQ	Substantially Equivalent	Honsun (Nantong) Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 31, 2025. 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.