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FDA 510(k)

Cionic Neural Sleeve NS-100

K-Number: K213622 · 2022-02-14

ApplicantCionic
Decision Date2022-02-14
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 2022-02-14 under approval number K213622. 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 2022-02-14. It is manufactured by Cionic. The 510(k) number is K213622.

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

Cionic Neural Sleeve NS-100 received FDA 510(k) clearance on 2022-02-14, under approval number K213622.

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

K221823Cionic Neural Sleeve NS-100

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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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