Cleared Special

Cionic Neural Sleeve NS-100

K221823 · Cionic · Physical Medicine
Jul 2022
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K221823 is an FDA 510(k) clearance for the Cionic Neural Sleeve NS-100, a Stimulator, Neuromuscular, External Functional (Class II — Special Controls, product code GZI), submitted by Cionic (San Francisco, US). The FDA issued a Cleared decision on July 21, 2022, 28 days after receiving the submission on June 23, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K221823 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2022
Decision Date July 21, 2022
Days to Decision 28 days
Submission Type Special
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