Cleared Traditional

K170564 - MyndMove System, MyndMove Functional Electrical Stimulator

K170564 is an FDA 510(k) clearance for MyndMove System, manufactured by Myndtec, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K170564 · Myndtec, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
184d
Days
Class 2
Risk

K170564 is an FDA 510(k) clearance for the MyndMove System, MyndMove Functional Electrical Stimulator. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Myndtec, Inc. (Mississauga, CA). The FDA issued a Cleared decision on August 30, 2017 after a review of 184 days - an extended review cycle.

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 Myndtec, Inc. devices

FDA 510(k) Submission Details - K170564

510(k) Number K170564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date August 30, 2017
Days to Decision 184 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
35d slower than avg
Panel avg: 149d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02266836 Completed Interventional Industry-sponsored

MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke

Clinical Feasibility and Usability of MyndMove Therapy for FES Facilitated Treatment of Subacute and Chronic Severe Hemiparesis of the Upper Limb Following Stroke

50
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Hemiparesis of the Upper Limb Following Stroke
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Debbie A Hebert, MSc(Kin)
Sponsor MyndTec Inc. (industry)
Started 2014-10-01 → Primary completion 2015-10-01
Primary outcome
Change in Upper Extremity Fugl-Meyer Assessment (UE-FMA)
Secondary outcome
Change in Functional Independence Measure and Self-Care Functional Independence Measure for the early subacute subjects
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 54
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K170564.
L300 Go System
K173682 · Bioness, Inc. · Mar 2018
ODFS Pace XL
K171396 · Odstock Medical, Ltd. · Jan 2018
Foot Drop System (Model XFT-2001D)
K162718 · Shenzhen Xft Medical Limited · Nov 2017
RT300 FES cycle ergometer
K162470 · Restorative Therapies, Inc. · Jul 2017
MyoCycle Home, MyoCycle Pro
K170132 · Myolyn, LLC · Apr 2017
RehaStim 2
K162683 · Hasomed GmbH · Feb 2017