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FDA 510(k)

Nova HD+

K-Number: K220938 · 2023-08-22

ApplicantAura Wellness, LLC
Decision Date2023-08-22
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Nova HD+ is the device name listed in this FDA 510(k) record. The listed applicant is Aura Wellness, LLC. It received FDA 510(k) clearance on 2023-08-22 under 510(k) number K220938. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova HD+?

Nova HD+ is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Aura Wellness, LLC. The 510(k) number is K220938.

When did Nova HD+ receive FDA 510(k) clearance?

Nova HD+ received FDA 510(k) clearance on 2023-08-22, under 510(k) number K220938.

Who is the listed applicant for Nova HD+?

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

What is the FDA product code for Nova HD+?

The FDA product code for Nova HD+ is NGX.

Other records listing Aura Wellness, LLC 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.

K250896Aura Wave

Related Devices (Code: NGX)

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.

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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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