Cleared Traditional

K151955 - YuGo System

K151955 is an FDA 510(k) clearance for YuGo System, manufactured by Biogaming , Ltd.. The device is a Class 2 Physical Medicine device with product code LXJ cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K151955 · Biogaming , Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
205d
Days
Class 2
Risk

K151955 is an FDA 510(k) clearance for the YuGo System. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Biogaming , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on February 5, 2016 after a review of 205 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.

FDA 510(k) Submission Details - K151955

510(k) Number K151955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2015
Decision Date February 05, 2016
Days to Decision 205 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
89d slower than avg
Panel avg: 116d · This submission: 205d
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 Consultant

Duet Medical Consulting , Ltd.
VERED NITZAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K151955.
UINCARE HOME
K172882 · Uincare Corp. · May 2018
MindMotionPRO
K162748 · Mindmaze SA · Apr 2017
Virtual Occupational Therapy Application (VOTA)
K163245 · Barron Associates, Inc. · Feb 2017
Vera
K150462 · Reflexion Health, Inc. · Oct 2015
Recovr Rehabilitation System
K151446 · Recovr,Inc · Sep 2015
Jintronix
K143034 · Jintronix, Inc. · Apr 2015
K151955 · YuGo System
Download PDF FDA Summary Biogaming , Ltd.