Neuvotion NeuStim NN-01

FDA 510(k) K240632 · Neuvotion, Inc.

Substantially Equivalent

510(k) numberK240632

Submission

Device name
Neuvotion NeuStim NN-01
Applicant
Neuvotion, Inc.
Stamford, CT, US
Received
March 6, 2024
Decision date
November 22, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZI – Stimulator, Neuromuscular, External Functional
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5810
Specialty
Neurology

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Questions and answers

When was Neuvotion NeuStim NN-01 cleared by the FDA?

Neuvotion NeuStim NN-01 (K240632) received a 510(k) decision of Substantially Equivalent on November 22, 2024, 261 days after the submission was received.

What is the product code of K240632?

The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.