# K040285: Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable Combo and Stim (General Line Dealer

- Pathway: 510(k) (Traditional)
- Applicant: Chattanooga Group
- Decided: Apr 12, 2004 after 66 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Feb 28, 2008 · Not classified · Z-1639-2008: Device may fail to administer therapy during use.

## Indications for use
For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES), Interferential and Piremodulated (IFS) Relaxation of Muscle Spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) Symptomatic relief or management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain For FES Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait For DC Continuous Mode [Relaxation of muscle spasm For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis b) Bursitis with slight calcification c) Myositis d) Soft tissue injuries e) Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness b) Capsular scarring

Source page: https://510kreport.com/device/K040285
Methodology: https://510kreport.com/methodology