Cleared Traditional

K163245 - Virtual Occupational Therapy Applicatio...

K163245 is an FDA 510(k) clearance for Virtual Occupational Therapy Applicatio..., manufactured by Barron Associates, Inc.. The device is a Class 2 Physical Medicine device with product code LXJ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K163245 · Barron Associates, Inc. · Physical Medicine device
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Feb 2017
Decision
102d
Days
Class 2
Risk

K163245 is an FDA 510(k) clearance for the Virtual Occupational Therapy Application (VOTA). Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Barron Associates, Inc. (Charlottesville, US). The FDA issued a Cleared decision on February 28, 2017 after a review of 102 days - within the typical 510(k) review window.

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 Barron Associates, Inc. devices

FDA 510(k) Submission Details - K163245

510(k) Number K163245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2016
Decision Date February 28, 2017
Days to Decision 102 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXJ Device Classification - Class 2, Special Controls

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.