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FDA 510(k)

Cionic Neural Sleeve NS-100

K-Number: K221823 · 2022-07-21

ApplicantCionic
Decision Date2022-07-21
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cionic Neural Sleeve NS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Cionic. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K221823. 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 Cionic Neural Sleeve NS-100?

Cionic Neural Sleeve NS-100 is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Cionic. The 510(k) number is K221823.

When did Cionic Neural Sleeve NS-100 receive FDA 510(k) clearance?

Cionic Neural Sleeve NS-100 received FDA 510(k) clearance on 2022-07-21, under 510(k) number K221823.

Who is the listed applicant for Cionic Neural Sleeve NS-100?

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

What is the FDA product code for Cionic Neural Sleeve NS-100?

The FDA product code for Cionic Neural Sleeve NS-100 is GZI.

Other records listing Cionic 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.

K243828CIONIC NEURAL SLEEVE (NS-200)K213622Cionic Neural Sleeve NS-100

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.K213925MyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC

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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