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FDA 510(k)

CIONIC NEURAL SLEEVE (NS-200)

K-Number: K243828 · 2025-05-02

ApplicantCionic, Inc.
Decision Date2025-05-02
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CIONIC NEURAL SLEEVE (NS-200) is the device name listed in this FDA 510(k) record. The listed applicant is Cionic, Inc.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K243828. 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-200)?

CIONIC NEURAL SLEEVE (NS-200) is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Cionic, Inc.. The 510(k) number is K243828.

When did CIONIC NEURAL SLEEVE (NS-200) receive FDA 510(k) clearance?

CIONIC NEURAL SLEEVE (NS-200) received FDA 510(k) clearance on 2025-05-02, under 510(k) number K243828.

Who is the listed applicant for CIONIC NEURAL SLEEVE (NS-200)?

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

What is the FDA product code for CIONIC NEURAL SLEEVE (NS-200)?

The FDA product code for CIONIC NEURAL SLEEVE (NS-200) is GZI.

Other records listing Cionic, 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.

K221823Cionic Neural Sleeve NS-100K213622Cionic 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.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100CionicK213925MyoCycle 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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