510(k) K240632

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

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