Cleared Traditional

K163245 - Virtual Occupational Therapy Application (VOTA)

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 116d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02706912 Completed Interventional Industry-sponsored

Virtual Occupational Therapy Application

22
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Stroke; Hemiparesis
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Barron Associates, Inc. (industry)
Started 2016-02-01 → Primary completion 2017-02-01
Primary outcome
Fugl-Meyer upper extremity assessment
Secondary outcome
Wolf Motor Function Test
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - LXJ Interactive Rehabilitation Exercise Devices

All 22
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K163245.
MindMotion(TM) GO
K173931 · Mindmaze SA · May 2018
UINCARE HOME
K172882 · Uincare Corp. · May 2018
MindMotionPRO
K162748 · Mindmaze SA · Apr 2017
YuGo System
K151955 · Biogaming , Ltd. · Feb 2016
Vera
K150462 · Reflexion Health, Inc. · Oct 2015
Recovr Rehabilitation System
K151446 · Recovr,Inc · Sep 2015
K163245 · Virtual Occupational Therapy Application (VOTA)
Download PDF FDA Summary Barron Associates, In…