Intelect Model 120

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

510(k) Number

K880235 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

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 Intelect Model 120 used for?

  The Intelect Model 120 is a low-voltage electrotherapy device designed for physical medicine applications. It provides controlled electrical stimulation to promote muscle contraction, enhance circulation, or relieve pain through transcutaneous electrical nerve stimulation (TENS). Clinicians use it in therapeutic settings where targeted muscle activation or pain management is required.

• Is the Intelect Model 120 reusable or single-use?

  The Intelect Model 120 is a reusable electrotherapy unit. Unlike disposable devices, it is intended for repeated use in clinical or home settings, provided it is maintained according to manufacturer guidelines. No sterilization is required for the device itself, but proper cleaning and inspection between uses are essential to ensure safety and performance.

• Does the Intelect Model 120 include electrodes or lead wires?

  No, the Intelect Model 120 is supplied as the core electrotherapy unit only. Lead wires and electrodes are not part of the device package. These accessories must be purchased separately to connect the device to the patient during treatment. Always ensure compatibility between the device and the chosen electrodes.

• What customization options does the Intelect Model 120 offer for treatments?

  The device features a timer and an adjustable rate knob, allowing clinicians to customize treatment duration and electrical stimulation intensity. This flexibility enables tailored therapy for muscle contraction, pain relief, or circulation improvement based on patient needs. Refer to the user manual for specific settings and safety guidelines.

• What regulatory pathway was followed for FDA clearance of the Intelect Model 120?

  The Intelect Model 120 received FDA 510(k) clearance under the Traditional 510(k) review pathway, with no third-party involvement. The clearance (K880235) was granted in 1988, and the device was determined to be substantially equivalent to a legally marketed predicate. This classification falls under product code IPF for physical medicine devices.