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ITRAC Cervical Traction System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131983

by Pivotal Health Solutions

Identifiers

510(k) Number
K131983 FDA 510(k)
FDA Product Code
ITH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5900 FDA 510(k)
Regulation Number
890.5900 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ITRAC Cervical Traction System is a powered traction device designed for cervical spine remodeling, classified under Equipment, Traction, Powered. It is intended to apply controlled traction to the cervical spine, aiding in the restoration of cervical curvature and reduction of forward head posture in patients with mechanical cervicogenic pain related to reduced cervical lordosis or altered posture.

This system is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K131983) as substantially equivalent to predicate devices. It operates within the scope of Physical Medicine, adhering to regulatory standards outlined in 21 CFR 890.5900. The device is intended for clinical use in settings such as chiropractic or physical therapy offices, where trained professionals administer traction under controlled conditions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: iTrac Spine Remodeling System - Pivotal Health Solutions, Home - iTrac Therapy, PDF Pivotal Health Solutions, Inc Phone (605) 753-0110 Fax (605) 882-8398

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pivotal Health Solutions

Sources (1)

  • FDA 510(k) K131983 24 fields · synced Oct 6, 2026