Cleared Traditional

K150462 - Vera

K150462 is an FDA 510(k) clearance for Vera, manufactured by Reflexion Health, Inc.. The device is a Class 2 Physical Medicine device with product code LXJ cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K150462 · Reflexion Health, Inc. · Physical Medicine device
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Oct 2015
Decision
249d
Days
Class 2
Risk

K150462 is an FDA 510(k) clearance for the Vera. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Reflexion Health, Inc. (San Diego, US). The FDA issued a Cleared decision on October 30, 2015 after a review of 249 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 Reflexion Health, Inc. devices

FDA 510(k) Submission Details - K150462

510(k) Number K150462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date October 30, 2015
Days to Decision 249 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
134d slower than avg
Panel avg: 115d · This submission: 249d
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.

Regulatory Peers - LXJ Interactive Rehabilitation Exercise Devices

All 15
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K150462.
MindMotionPRO
K162748 · Mindmaze SA · Apr 2017
Virtual Occupational Therapy Application (VOTA)
K163245 · Barron Associates, Inc. · Feb 2017
YuGo System
K151955 · Biogaming , Ltd. · Feb 2016
Recovr Rehabilitation System
K151446 · Recovr,Inc · Sep 2015
Jintronix
K143034 · Jintronix, Inc. · Apr 2015
SMART (SMART-D, SMART-DX)
K131660 · Bts S.P.A. · Apr 2014