Cleared Traditional

K212149 - MyndMove 2.0

K212149 is an FDA 510(k) clearance for MyndMove 2.0, manufactured by Myndtec, Inc.. The device is a Class 2 Physical Medicine device with product code GZI cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K212149 · Myndtec, Inc. · Physical Medicine device
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Mar 2022
Decision
237d
Days
Class 2
Risk

K212149 is an FDA 510(k) clearance for the MyndMove 2.0. 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 March 3, 2022 after a review of 237 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5810 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Myndtec, Inc. devices

FDA 510(k) Submission Details - K212149

510(k) Number K212149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2021
Decision Date March 03, 2022
Days to Decision 237 days
Submission Type Traditional
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
122d slower than avg
Panel avg: 115d · This submission: 237d
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 19
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