Cleared Traditional

K213925 - MyoCycle MC-2 (Home / Home + / Pro / Pro +)

K213925 is an FDA 510(k) clearance for MyoCycle MC-2 (Home / Home + / Pro / Pro +), manufactured by Myolyn, LLC. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K213925 · Myolyn, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
130d
Days
Class 2
Risk

K213925 is an FDA 510(k) clearance for the MyoCycle MC-2 (Home / Home + / Pro / Pro +). Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Myolyn, LLC (Gainesville, US). The FDA issued a Cleared decision on April 25, 2022 after a review of 130 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 Myolyn, LLC devices

FDA 510(k) Submission Details - K213925

510(k) Number K213925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2021
Decision Date April 25, 2022
Days to Decision 130 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
18d faster than avg
Panel avg: 148d · This submission: 130d
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 K213925.
MyndMove, MyndMove 2.0
K233006 · Myndtec, Inc. · Jun 2024
EvoWalk 1.0 System
K230997 · Evolution Devices, Inc. · Dec 2023
Cionic Neural Sleeve NS-100
K221823 · Cionic · Jul 2022
MyndMove 2.0
K212149 · Myndtec, Inc. · Mar 2022
Cionic Neural Sleeve NS-100
K213622 · Cionic · Feb 2022
MStim Drop Model: LGT-233
K202110 · Guangzhou Longest Science & Technology Co., Ltd. · Nov 2021