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FDA 510(k)

ZIDA Wearable Neuromodulation System

K-Number: K192731 · 2021-03-19

Decision Date2021-03-19
Product CodeNAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ZIDA Wearable Neuromodulation System is a medical device manufactured by Exodus Innovations. It received FDA 510(k) clearance on 2021-03-19 under approval number K192731. The device is classified under product code NAM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIDA Wearable Neuromodulation System?

ZIDA Wearable Neuromodulation System is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Exodus Innovations. The 510(k) number is K192731.

When was ZIDA Wearable Neuromodulation System approved by the FDA?

ZIDA Wearable Neuromodulation System received FDA 510(k) clearance on 2021-03-19, under approval number K192731.

What company makes ZIDA Wearable Neuromodulation System?

ZIDA Wearable Neuromodulation System is manufactured by Exodus Innovations.

What is the FDA product code for ZIDA Wearable Neuromodulation System?

The FDA product code for ZIDA Wearable Neuromodulation System is NAM.

Related Clinical Trials

Related Devices (Code: NAM)

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.