Cleared Traditional

K212149 - MyndMove 2.0 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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
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