Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit

Q: What is the product code of K111767?

The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.

FDA 510(k) K111767 · Ness-Neuromuscular Electrical Stimulation Systems

Substantially Equivalent

510(k) numberK111767

Submission

Device name: Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit
Applicant: Ness-Neuromuscular Electrical Stimulation Systems
Ra'Anana, IL
Received: June 23, 2011
Decision date: September 15, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GZI – Stimulator, Neuromuscular, External Functional
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5810
Specialty: Neurology

Other 510(k)s with product code GZI

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K242704	Synchrony (20-3000)GZI · Traditional	Synapse Biomedical, Inc.	06/05/2025SE
K243828	Cionic Neural Sleeve (NS-200)GZI · Traditional	Cionic, Inc.	05/02/2025SE
K240632	Neuvotion NeuStim NN-01GZI · Traditional	Neuvotion, Inc.	11/22/2024SE
K233006	MyndMove, MyndMove 2.0GZI · Traditional	Myndtec, Inc.	06/25/2024SE
K230997	EvoWalk 1.0 SystemGZI · Traditional	Evolution Devices, Inc.	12/28/2023SE
K221823	Cionic Neural Sleeve NS-100GZI · Special	Cionic	07/21/2022SE
K213925	MyoCycle MC-2 (Home / Home + / Pro / Pro +)GZI · Traditional	Myolyn, LLC	04/25/2022SE
K212149	MyndMove 2.0GZI · Traditional	Myndtec, Inc.	03/03/2022SE
K213622	Cionic Neural Sleeve NS-100GZI · Traditional	Cionic	02/14/2022SE
K202110	MStim Drop Model: LGT-233GZI · Traditional	Guangzhou Longest Science & Technology Co., Ltd.	11/05/2021SE

More from Guangzhou Longest Science & Technology Co., Ltd.

510(k)	Device	Decision
K080219	Modification To:Ness L300GZI · Special	02/28/2008SE
K053468	Ness L300GZI · Traditional	07/07/2006SE
K031900	HandmasterGZI · Special	08/08/2003SE
K024279	Ness Children SystemIPG · Traditional	02/05/2003SE
K022776	Ness SystemIPF · Special	09/11/2002SE
K012823	Modification to HandmasterGZI · Traditional	11/14/2001SE

Questions and answers

When was Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit cleared by the FDA?

Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit (K111767) received a 510(k) decision of Substantially Equivalent on September 15, 2011, 84 days after the submission was received.

What is the product code of K111767?

The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.