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510(k) K240632

Neuvotion NeuStim NN-01 by Neuvotion, Inc. — Product Code GZI

K240632 is an FDA 510(k) premarket notification submitted by Neuvotion, Inc. for the device "Neuvotion NeuStim NN-01". The FDA issued a decision of Substantially Equivalent on November 22, 2024. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
March 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

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FDA data resources