Forte Model CPS Ultrasound

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K982829 ↗

FDA Product Code

IMI

Device Class

Class II

Regulation

21 CFR Part 890.5300

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Triton/Tru-Trac/Tx Traction Devices

  Class II

  FDA 510(k) K051938 Active Cleared 21 Sep 2005

• Kin-Com Asymmetrical Back System

  Class II

  FDA 510(k) K911805 Active Cleared 3 Jul 1991

• Vectra Stim Models 200 and 400

  Class II

  FDA 510(k) K982321 Active Cleared 1 Feb 1999

• Ist-200 Intersegmental Traction Table

  Class II

  FDA 510(k) K900304 Active Cleared 11 Apr 1990

• Intelect Swd 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601

  Class II

  FDA 510(k) K083433 Active Cleared 18 Mar 2009

• Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable Combo and Stim (General Line Dealer

  Class II

  FDA 510(k) K040285 Active Cleared 12 Apr 2004

See all devices from Chattanooga Group, Inc. →

• What is the Forte Model CPS Ultrasound designed for?

  The Forte Model CPS Ultrasound is a therapeutic device classified as Ultrasonic Diathermy for Applying Therapeutic Deep Heat. It is specifically designed to generate controlled ultrasound energy, heating targeted tissues to a range of 40°C to 45°C. This promotes tissue repair, reduces pain, and alleviates inflammation, making it particularly useful for musculoskeletal conditions in physical medicine and rehabilitation settings.

• Is the Forte Model CPS Ultrasound sterile upon delivery?

  No, the Forte Model CPS Ultrasound is not sterile when delivered. It is intended as a reusable medical device for clinical environments like physical therapy and rehabilitation clinics. Proper cleaning and maintenance, as outlined by the manufacturer, are required before use to ensure safety and performance.

• How is the Forte Model CPS Ultrasound supplied and what are its regulatory details?

  The Forte Model CPS Ultrasound is supplied as a reusable device and is FDA-cleared under a 510(k) submission (K982829). It falls under Device Class II regulatory classification and is intended for use in clinical settings. The device adheres to standard electrotherapy safety protocols, though specific MRI safety information is not provided.

• What distinguishes the Forte Model CPS Ultrasound from other therapeutic ultrasound devices?

  The Forte Model CPS Ultrasound is distinguished by its advanced digital signal processing, which enhances precision and portability in clinical applications. Unlike some other devices, it is explicitly designed for delivering therapeutic deep heat within a controlled range of 40°C to 45°C, making it particularly effective for soft tissue treatment in physical medicine and rehabilitation.

• What storage and handling guidelines should be followed for the Forte Model CPS Ultrasound?

  The Forte Model CPS Ultrasound should be stored and handled according to general medical device guidelines to ensure longevity and optimal performance. Since it is reusable, proper cleaning and maintenance procedures must be followed after each use. Avoid exposure to extreme temperatures, moisture, or physical damage, and store in a clean, dry environment as recommended by the manufacturer.