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FDA 510(k)

NXPRO Neuromuscular Electrical Stimulation Device

K-Number: K191181 · 2019-10-11

ApplicantNeux Technologies, Inc.
Decision Date2019-10-11
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NXPRO Neuromuscular Electrical Stimulation Device is a medical device manufactured by Neux Technologies, Inc.. It received FDA 510(k) clearance on 2019-10-11 under approval number K191181. 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 NXPRO Neuromuscular Electrical Stimulation Device?

NXPRO Neuromuscular Electrical Stimulation Device is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Neux Technologies, Inc.. The 510(k) number is K191181.

When was NXPRO Neuromuscular Electrical Stimulation Device approved by the FDA?

NXPRO Neuromuscular Electrical Stimulation Device received FDA 510(k) clearance on 2019-10-11, under approval number K191181.

What company makes NXPRO Neuromuscular Electrical Stimulation Device?

NXPRO Neuromuscular Electrical Stimulation Device is manufactured by Neux Technologies, Inc..

What is the FDA product code for NXPRO Neuromuscular Electrical Stimulation Device?

The FDA product code for NXPRO Neuromuscular Electrical Stimulation Device is NGX.

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT06868914 Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) NOT_YET_RECRUITING NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED

Related PubMed Literature

PMID: 41858417 AI-Driven Medical Device Risk Management: A New Paradigm Integrating Large Language Models and Prompt Engineering for Standard-Risk Knowledge Graph Construction and Application. Risk management and healthcare policy (2026)

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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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