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FDA 510(k)

Modius Stress

K-Number: K232253 · 2024-03-27

ApplicantNeurovalens Limited
Decision Date2024-03-27
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Modius Stress is the device name listed in this FDA 510(k) record. The listed applicant is Neurovalens Limited. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K232253. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modius Stress?

Modius Stress is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Neurovalens Limited. The 510(k) number is K232253.

When did Modius Stress receive FDA 510(k) clearance?

Modius Stress received FDA 510(k) clearance on 2024-03-27, under 510(k) number K232253.

Who is the listed applicant for Modius Stress?

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

What is the FDA product code for Modius Stress?

The FDA product code for Modius Stress is QJQ.

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NCT06956105Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in AdolescentsCOMPLETED

Other records listing Neurovalens Limited 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.

K230826Modius Sleep

Related Devices (Code: QJQ)

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.

K252951Genesis SleepNeurofield, Inc.K230826Modius SleepNeurovalens , Ltd.K182311CervellaInnovative Neurological Devices, 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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