Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cumulus Functional Neurophysiology Platform

K-Number: K221963 · 2023-04-27

ApplicantCumulus Neuroscience Limited
Decision Date2023-04-27
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cumulus Functional Neurophysiology Platform is a medical device manufactured by Cumulus Neuroscience Limited. It received FDA 510(k) clearance on 2023-04-27 under approval number K221963. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cumulus Functional Neurophysiology Platform?

Cumulus Functional Neurophysiology Platform is a medical device that received FDA 510(k) clearance on 2023-04-27. It is manufactured by Cumulus Neuroscience Limited. The 510(k) number is K221963.

When was Cumulus Functional Neurophysiology Platform approved by the FDA?

Cumulus Functional Neurophysiology Platform received FDA 510(k) clearance on 2023-04-27, under approval number K221963.

What company makes Cumulus Functional Neurophysiology Platform?

Cumulus Functional Neurophysiology Platform is manufactured by Cumulus Neuroscience Limited.

What is the FDA product code for Cumulus Functional Neurophysiology Platform?

The FDA product code for Cumulus Functional Neurophysiology Platform is GWQ.

Related Clinical Trials

NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT07603609 Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain RECRUITING NCT06921265 Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia ENROLLING_BY_INVITATION NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING

Related Devices (Code: GWQ)

K163163XLTEK EMU40EX EEG HeadboxNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K162595Trex_HDNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K150498Discovery 24Brainmaster Technologies, Inc. K170138NEURONAUTEBioserenity K171781eVox SystemEvoke Neuroscience, Inc. K171124Nihon Kohden Wireless Input Unit WEE-1200Nihon Kohden Corporation

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.

↑