Interceptor, 662-01

Q: What is the product code of K844279?

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) K844279 · Intermedics, Inc.

Substantially Equivalent

510(k) numberK844279

Submission

Device name: Interceptor, 662-01
Applicant: Intermedics, Inc.
Freeport, TX, US
Received: November 5, 1984
Decision date: January 24, 1985
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
K954610	Model 430-07 Endocardial Pacing LeadDTB · Traditional	12/16/1996PT
K955122	Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional	11/04/1996ST
K962174	Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional	08/21/1996ST
K955550	Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional	06/19/1996ST
K960281	Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional	06/18/1996ST
K954719	Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional	02/27/1996ST
K933278	Intermedics Triangle Chest Probe Model 526-04KRG · Traditional	03/15/1995SE
K922042	Cardifix Endocardial Pacing LeadDTB · Traditional	04/29/1993SESP
K922972	Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional	01/22/1993SESP
K920530	Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional	03/17/1992SE

Questions and answers

When was Interceptor, 662-01 cleared by the FDA?

Interceptor, 662-01 (K844279) received a 510(k) decision of Substantially Equivalent on January 24, 1985, 80 days after the submission was received.

What is the product code of K844279?

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