FDA 510(k)

Neu Platform

K-Number: K250153 · 2025-04-25

Decision Date2025-04-25

Product CodeGYD

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Neu Platform is the device name listed in this FDA 510(k) record. The listed applicant is Neuhealth Digital , Ltd.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K250153. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neu Platform?

Neu Platform is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Neuhealth Digital , Ltd.. The 510(k) number is K250153.

When did Neu Platform receive FDA 510(k) clearance?

Neu Platform received FDA 510(k) clearance on 2025-04-25, under 510(k) number K250153.

Who is the listed applicant for Neu Platform?

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

What is the FDA product code for Neu Platform?

The FDA product code for Neu Platform is GYD.

Related Devices (Code: GYD)

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.

K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalEmpatica S.r.l.K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB K221772NeuroRPMNew Touch Digital, Inc.K220820Parky AppH2o Bilisim Yazilim K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.

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.