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 a medical device manufactured by Cionic. It received FDA 510(k) clearance on 2022-07-21 under approval 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. It is manufactured by Cionic. The 510(k) number is K221823.

When was Cionic Neural Sleeve NS-100 approved by the FDA?

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

What company makes Cionic Neural Sleeve NS-100?

Cionic Neural Sleeve NS-100 is manufactured by Cionic.

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 Devices by Cionic

K213622Cionic Neural Sleeve NS-100

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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.