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FDA 510(k)

NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT

K-Number: K111767 · 2011-09-15

ApplicantNess-Neuromuscular Electrical Stimulation Systems
Decision Date2011-09-15
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ness-Neuromuscular Electrical Stimulation Systems. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K111767. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT?

NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Ness-Neuromuscular Electrical Stimulation Systems. The 510(k) number is K111767.

When did NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT receive FDA 510(k) clearance?

NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT received FDA 510(k) clearance on 2011-09-15, under 510(k) number K111767.

Who is the listed applicant for NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT?

The FDA 510(k) record lists Ness-Neuromuscular Electrical Stimulation Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT?

The FDA product code for NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT is GZI.

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Other records listing Ness-Neuromuscular Electrical Stimulation Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K080219MODIFICATION TO:NESS L300K053468NESS L300K031900HANDMASTERK024279NESS CHILDREN SYSTEMK022776NESS SYSTEMK012823MODIFICATION TO HANDMASTER

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Related Devices (Code: GZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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