Cleared Traditional

K162748 - MindMotionPRO (FDA 510(k) Clearance)

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

K162748 · Mindmaze SA · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
206d
Days
Class 2
Risk

K162748 is an FDA 510(k) clearance for the MindMotionPRO. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Mindmaze SA (Lausanne, CH). The FDA issued a Cleared decision on April 24, 2017 after a review of 206 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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 Mindmaze SA devices

Submission Details

510(k) Number K162748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date April 24, 2017
Days to Decision 206 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 115d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXJ Interactive Rehabilitation Exercise Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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.