Cleared Traditional

CIONIC NEURAL SLEEVE (NS-200)

K243828 · Cionic, Inc. · Physical Medicine
May 2025
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K243828 is an FDA 510(k) clearance for the CIONIC NEURAL SLEEVE (NS-200), a Stimulator, Neuromuscular, External Functional (Class II — Special Controls, product code GZI), submitted by Cionic, Inc. (Scotts Valley, US). The FDA issued a Cleared decision on May 2, 2025, 140 days after receiving the submission on December 13, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K243828 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date May 02, 2025
Days to Decision 140 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

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