MEDS-3 Neuromuscular Stimulator

Q: What is the product code of K023443?

The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.

FDA 510(k) K023443 · Medical Equipment Device Specialists

Substantially Equivalent

510(k) numberK023443

Submission

Device name: MEDS-3 Neuromuscular Stimulator
Applicant: Medical Equipment Device Specialists
San Juan Capistrano, CA, US
Received: October 15, 2002
Decision date: January 13, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5890
Specialty: Neurology

Other 510(k)s with product code GZJ

510(k)	Device	Applicant	Decision
K252712	STIMPOD NMS460 Nerve StimulatorGZJ · Traditional	Algiamed Technologies USA, Inc.	05/28/2026SE
K252767	actiTENS miniGZJ · Traditional	Sublimed	01/16/2026SE
K252236	CP Relief Wand Rx - TENS/NMESGZJ · Special	N & C Holdings, LLC	08/15/2025SE
K232441	Unipro (K-UNIPRO-US)GZJ · Traditional	Tenscare, Ltd.	08/30/2024SE
K241228	TENSWaveGZJ · Abbreviated	Zynex Medical Officer	08/27/2024SE
K233046	Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional	Oriental Inspiration Limited	04/19/2024SE
K222879	Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional	Wuxi Jiajian Medical Instrument Co., Ltd.	01/24/2023SE
K212618	iRelieve Microcurrent Pain Relief SystemGZJ · Traditional	Fast Track Technologies, Inc.	09/14/2022SE
K213802	StimOnTM Pain Relief System (GM2439)GZJ · Traditional	Gimer Medical Co., Ltd.	08/26/2022SE
K220578	Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional	Bozhou Rongjian Medical Appliance Co., Ltd.	05/25/2022SE

More from Bozhou Rongjian Medical Appliance Co., Ltd.

510(k)	Device	Decision
K040193	Model GST-1GZJ · Traditional	04/27/2004SE
K032055	MEDS-4-INF+GZJ · Traditional	10/03/2003SE
K023446	MEDS-3 Neuromuscular StimulatorIPF · Traditional	01/13/2003SE
K023439	MEDS-4 Neuromuscular StimulatorIPF · Traditional	01/13/2003SE
K023435	MEDS-4 Neuromuscular StimulatorGZJ · Traditional	01/13/2003SE

Questions and answers

When was MEDS-3 Neuromuscular Stimulator cleared by the FDA?

MEDS-3 Neuromuscular Stimulator (K023443) received a 510(k) decision of Substantially Equivalent on January 13, 2003, 90 days after the submission was received.

What is the product code of K023443?

The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.