# K031116: Vectra (Intelect) Epr Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: Chattanooga Group
- Decided: Dec 3, 2003 after 239 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- 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-1636-2008: Device may fail to administer therapy during use.

## Indications for use
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/K031116
Methodology: https://510kreport.com/methodology