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FDA 510(k)

NESS L300

K-Number: K053468 · 2006-07-07

ApplicantNess-Neuromuscular Electrical Stimulation Systems
Decision Date2006-07-07
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NESS L300 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 2006-07-07 under 510(k) number K053468. 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 L300?

NESS L300 is a medical device that received FDA 510(k) clearance on 2006-07-07. The listed applicant is Ness-Neuromuscular Electrical Stimulation Systems. The 510(k) number is K053468.

When did NESS L300 receive FDA 510(k) clearance?

NESS L300 received FDA 510(k) clearance on 2006-07-07, under 510(k) number K053468.

Who is the listed applicant for NESS L300?

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 L300?

The FDA product code for NESS L300 is GZI.

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.

K111767NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KITK080219MODIFICATION TO:NESS 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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