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Neuvotion NeuStim NN-01

by Neuvotion, Inc.

510(k) K240632

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240632 Date22 Nov 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZI
Device Class
Class II
Regulation
21 CFR Part 882.5810
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neuvotion NeuStim NN-01 is an External Functional Neuromuscular Stimulator, classified under FDA regulation 21 CFR 882.5810. This device delivers targeted electrical stimulation via disposable electrodes (Flexor, Extensor, Thumb) with 181 addressable contacts to facilitate neuromuscular activation in the right arm and hand.

Intended for single-use, the device is designed for use in clinical and home settings to aid recovery after stroke or C5 spinal cord injury. Supplied as a reusable voltage-controlled stimulator paired with disposable electrodes, it requires no MRI compatibility considerations. Authorized under FDA 510(k) clearance (K240632), it adheres to Class II regulatory standards for neuromuscular stimulators.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical conditions is the Neuvotion NeuStim NN-01 designed to support recovery for, and how does it work?

    The Neuvotion NeuStim NN-01 is designed to aid recovery for patients who have experienced a stroke or a C5 spinal cord injury, specifically targeting the right arm and hand. It works by delivering targeted electrical stimulation through disposable electrodes (Flexor, Extensor, Thumb) with 181 addressable contacts to facilitate neuromuscular activation, helping to restore function through repeated, controlled stimulation sessions.

  • Is the Neuvotion NeuStim NN-01 intended for use in both clinical and home settings, and how is it supplied?

    Yes, the Neuvotion NeuStim NN-01 is designed for use in both clinical and home settings. It is supplied as a reusable voltage-controlled stimulator paired with single-use disposable electrodes, ensuring hygiene and ease of use for multiple patients or repeated sessions at home.

  • Are the disposable electrodes for the Neuvotion NeuStim NN-01 reusable, and if not, how should they be handled after use?

    The disposable electrodes for the Neuvotion NeuStim NN-01 are intended for single-use only. After use, they should be discarded properly to maintain sterility and prevent cross-contamination, as they are not designed for reuse.

  • Does the Neuvotion NeuStim NN-01 require any special considerations for storage, such as temperature or handling?

    The Neuvotion NeuStim NN-01 itself is a reusable device, and while specific storage instructions for the reusable stimulator aren’t detailed in the data, it’s generally recommended to store it in a clean, dry place away from direct sunlight or extreme temperatures. The disposable electrodes should be stored according to manufacturer guidelines, typically in a sealed, sterile packaging until use.

  • What regulatory pathway was followed for FDA clearance of the Neuvotion NeuStim NN-01, and what does this mean for its use?

    The Neuvotion NeuStim NN-01 received FDA clearance through a traditional 510(k) pathway, specifically under the classification 21 CFR 882.5810 for External Functional Neuromuscular Stimulators. This clearance was granted after demonstrating substantial equivalence to a legally marketed predicate device, confirming its safety and effectiveness for the intended use in neuromuscular activation for stroke and C5 spinal cord injury recovery. The clearance type is 'Traditional,' and it adheres to Class II regulatory standards.