Cleared Traditional

K240632 - Neuvotion NeuStim NN-01
(FDA 510(k) Clearance)

K240632 · Neuvotion, Inc. · Neurology
Nov 2024
Decision
261d
Days
Class 2
Risk

K240632 is an FDA 510(k) clearance for the Neuvotion NeuStim NN-01. This device is classified as a Stimulator, Neuromuscular, External Functional (Class II — Special Controls, product code GZI).

Submitted by Neuvotion, Inc. (Stamford, US). The FDA issued a Cleared decision on November 22, 2024, 261 days after receiving the submission on March 6, 2024.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K240632 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2024
Decision Date November 22, 2024
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZI — Stimulator, Neuromuscular, External Functional
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5810