Cleared Traditional

ITRAC CERVICAL TRACTION SYSTEM

K131983 · Pivotal Health Solutions · Physical Medicine

Sep 2014

Decision

439d

Days

Class 2

Risk

About This 510(k) Submission

K131983 is an FDA 510(k) clearance for the ITRAC CERVICAL TRACTION SYSTEM, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Pivotal Health Solutions (Watertown, US). The FDA issued a Cleared decision on September 10, 2014, 439 days after receiving the submission on June 28, 2013. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K131983 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2013
Decision Date	September 10, 2014
Days to Decision	439 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF