Cleared Traditional

K073154 - FACTS HAND AND PINCH GRIP COMBO

K073154 is an FDA 510(k) clearance for FACTS HAND AND PINCH GRIP COMBO, manufactured by Global Services Group, LLC. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K073154 · Global Services Group, LLC · Neurology device
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Feb 2008
Decision
98d
Days
Class 2
Risk

K073154 is an FDA 510(k) clearance for the FACTS HAND AND PINCH GRIP COMBO. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Global Services Group, LLC (Williamsburg, US). The FDA issued a Cleared decision on February 14, 2008 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Global Services Group, LLC devices

FDA 510(k) Submission Details - K073154

510(k) Number K073154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2007
Decision Date February 14, 2008
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBB Device Classification - Class 2, Special Controls

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
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 Neurology devices follow this clearance model.

Regulatory Peers - LBB Dynamometer, Ac-powered

All 8
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K073154.
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
K981730 · Nk Biotechnical Corp. · Jul 1998
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K980363 · Orofacial Dynamics · Apr 1998
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K964933 · Mekanika, Inc. · Feb 1997
DYNAMOMETER
K964685 · John Chatillon & Sons, Inc. · Jan 1997
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K901290 · Chattanooga Group, Inc. · Oct 1990
KIN-COM JR
K881388 · Chattanooga Group, Inc. · Apr 1988