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FDA 510(k)

WALKAIDE SYSTEM

K-Number: K123972 · 2013-04-01

ApplicantInnovative Neurotronics, Inc.
Decision Date2013-04-01
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WALKAIDE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Neurotronics, Inc.. It received FDA 510(k) clearance on 2013-04-01 under 510(k) number K123972. 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 WALKAIDE SYSTEM?

WALKAIDE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-01. The listed applicant is Innovative Neurotronics, Inc.. The 510(k) number is K123972.

When did WALKAIDE SYSTEM receive FDA 510(k) clearance?

WALKAIDE SYSTEM received FDA 510(k) clearance on 2013-04-01, under 510(k) number K123972.

Who is the listed applicant for WALKAIDE SYSTEM?

The FDA 510(k) record lists Innovative Neurotronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WALKAIDE SYSTEM?

The FDA product code for WALKAIDE SYSTEM is GZI.

Related Clinical Trials

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.

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Other records listing Innovative Neurotronics, Inc. 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.

K052329WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000

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

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

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