Cleared Special

K221823 - Cionic Neural Sleeve NS-100 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221823 · Cionic · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
28d
Days
Class 2
Risk

K221823 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 July 21, 2022 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5810 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cionic devices

Submission Details

510(k) Number K221823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Physical Medicine devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 60
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K221823.
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K242704 · Synapse Biomedical, Inc. · Jun 2025
CIONIC NEURAL SLEEVE (NS-200)
K243828 · Cionic, Inc. · May 2025
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K230997 · Evolution Devices, Inc. · Dec 2023
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