Dual Channel TENS, Pulsar Remote Contrl

Q: What is the product code of K842888?

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) K842888 · Cryomedics, Inc.

Substantially Equivalent

510(k) numberK842888

Submission

Device name: Dual Channel TENS, Pulsar Remote Contrl
Applicant: Cryomedics, Inc.
Bridgeport, CT, US
Received: July 23, 1984
Decision date: January 14, 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
K851152	MC-4000 Surgical Instruments CardiovascularDWS · Traditional	06/24/1985SE
K844431	Yn CO2 Laser System 30WHHR · Traditional	02/25/1985SE
K842959	MC-4000 Console & ProbesGEH · Traditional	12/07/1984SE
K842704	MT-700 MT-750 FT-350GEH · Traditional	08/01/1984SE
K801730	Krymed System 4001 Tilt ScopeHEX · Traditional	08/13/1980SE
K800335	Krymed Liquid Nitrogen CryojetGEH · Traditional	04/04/1980SE

Questions and answers

When was Dual Channel TENS, Pulsar Remote Contrl cleared by the FDA?

Dual Channel TENS, Pulsar Remote Contrl (K842888) received a 510(k) decision of Substantially Equivalent on January 14, 1985, 175 days after the submission was received.

What is the product code of K842888?

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