K-Disperse

Q: When was K-Disperse cleared by the FDA?

K-Disperse (K921679) received a 510(k) decision of Substantially Equivalent on October 6, 1992, 181 days after the submission was received.

Q: What is the product code of K921679?

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) K921679 · Katecho, Inc.

Substantially Equivalent

510(k) numberK921679

Submission

Device name: K-Disperse
Applicant: Katecho, Inc.
Des Moines, IA, US
Received: April 8, 1992
Decision date: October 6, 1992
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
K012404	K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional	10/12/2001SE
K010543	KM-30 TENS ElectrodeGXY · Traditional	05/23/2001SE
K003228	K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AMKJ · Traditional	12/14/2000SE
K002806	K-Defib/Pace, Model KDP-60AMKJ · Traditional	11/21/2000SE
K000870	KM-10 TENS ElectrodeGXY · Traditional	11/07/2000SE
K993745	K-Defib/Pace Adult Electrode, Model KDP-80MKJ · Traditional	02/03/2000SE
K991007	K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60MKJ · Traditional	08/23/1999SE
K981737	K-Defib/Pace Adult Electrode Model Number KDP-60MKJ · Traditional	12/09/1998SE
K954504	K-Defib/Pace Pediatric ElectrodeMKJ · Traditional	11/17/1995SE
K934692	K-Defib/Pace Pediatric ElectrodeMKJ · Traditional	01/24/1995SE

Questions and answers

When was K-Disperse cleared by the FDA?

K-Disperse (K921679) received a 510(k) decision of Substantially Equivalent on October 6, 1992, 181 days after the submission was received.

What is the product code of K921679?

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