E.W.L. P-Tens Model(Tens

Q: What is the product code of K813601?

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) K813601 · Electronic Waveform Laboratory, Inc.

Substantially Equivalent

510(k) numberK813601

Submission

Device name: E.W.L. P-Tens Model(Tens
Applicant: Electronic Waveform Laboratory, Inc.
Walker, MI, US
Received: December 28, 1981
Decision date: March 19, 1982
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K103738	H-WaveIPF · Special	06/01/2011SE
K081998	H-Wave SportNGX · Traditional	07/09/2009SE
K915230	H Wave Muscle StimulatorIPF · Traditional	05/08/1992SE
K873604	E.W.L. P-Tens/H-Wave for General DentistryLWM · Traditional	04/12/1988SE
K862121	E.W.L. P-Tens/H-WaveKZM · Traditional	06/17/1987SE

Questions and answers

When was E.W.L. P-Tens Model(Tens cleared by the FDA?

E.W.L. P-Tens Model(Tens (K813601) received a 510(k) decision of Substantially Equivalent on March 19, 1982, 81 days after the submission was received.

What is the product code of K813601?

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