Cleared Special

K192474 - VERA

K192474 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 Special 510(k) pathway after a 30-day FDA review.

K192474 · Reflexion Health, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
30d
Days
Class 2
Risk

K192474 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 10, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192474

510(k) Number K192474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2019
Decision Date October 10, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 116d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 26
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K192474.
Vera
K182333 · Reflexion Health, Inc. · Apr 2019
DARI Health
K180880 · Scientific Analytics, Inc. · Mar 2019
Qualisys Clinical System
K171547 · Qualisys AB · Aug 2018
MindMotion(TM) GO
K173931 · Mindmaze SA · May 2018
UINCARE HOME
K172882 · Uincare Corp. · May 2018
MindMotionPRO
K162748 · Mindmaze SA · Apr 2017
K192474 · VERA
Download PDF Reflexion Health, Inc.