Cleared Traditional

K182333 - Vera

K182333 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 224-day FDA review.

K182333 · Reflexion Health, Inc. · Physical Medicine device
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Apr 2019
Decision
224d
Days
Class 2
Risk

K182333 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 April 9, 2019 after a review of 224 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 - K182333

510(k) Number K182333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2018
Decision Date April 09, 2019
Days to Decision 224 days
Submission Type Traditional
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
109d slower than avg
Panel avg: 115d · This submission: 224d
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 K182333.
VERA
K192474 · Reflexion Health, Inc. · Oct 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