Cleared Traditional

Cionic Neural Sleeve NS-100

K213622 · Cionic · Neurology
Feb 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K213622 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 February 14, 2022, 90 days after receiving the submission on November 16, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K213622 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2021
Decision Date February 14, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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