Cleared Traditional

K073154 - FACTS HAND AND PINCH GRIP COMBO
(FDA 510(k) Clearance)

K073154 · Global Services Group, LLC · Neurology

Feb 2008

Decision

98d

Days

Class 2

Risk

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

Submitted by Global Services Group, LLC (Williamsburg, US). The FDA issued a Cleared decision on February 14, 2008, 98 days after receiving the submission on November 8, 2007.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1240.

Submission Details

510(k) Number	K073154 FDA.gov
FDA Decision	Cleared 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