Cleared Traditional

K213622 - Cionic Neural Sleeve NS-100

K213622 is an FDA 510(k) clearance for Cionic Neural Sleeve NS-100, manufactured by Cionic. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K213622 is an FDA 510(k) clearance for the Cionic Neural Sleeve NS-100. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Cionic (San Francisco, US). The FDA issued a Cleared decision on February 14, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cionic devices

FDA 510(k) Submission Details - K213622

510(k) Number K213622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZI Device Classification - Class 2, Special Controls

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 19
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K213622.
Cionic Neural Sleeve NS-100
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K202110 · Guangzhou Longest Science & Technology Co., Ltd. · Nov 2021
Nerve and Muscle Stimulator
K193276 · Shenzhen Xft Medical Limited · Sep 2020
L100 Go System
K200262 · Bioness, Inc. · Mar 2020