Cleared Traditional

K233006 - MyndMove, MyndMove 2.0 (FDA 510(k) Clearance)

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

K233006 · Myndtec, Inc. · Physical Medicine device
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Jun 2024
Decision
277d
Days
Class 2
Risk

K233006 is an FDA 510(k) clearance for the MyndMove, 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 June 25, 2024 after a review of 277 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 K233006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date June 25, 2024
Days to Decision 277 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
162d slower than avg
Panel avg: 115d · This submission: 277d
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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