# K982324: Vectra Pro Models 2 and 4

- Pathway: 510(k) (Traditional)
- Applicant: Chattanooga Group, Inc.
- Decided: Feb 1, 1999 after 214 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 4 cite it directly.
0 of 68 devices 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.

## Most influential descendants
- K023231: Elfcare Device, Models 314A Through 314G (2003), 63 descendants of its own
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own
- K090094: Zeltiq System (2009), 32 descendants of its own

## Indications for use
For Ultrasound Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C. For VMS, Russian, Monophasic Hi-Volt 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 For Microcurrent, Interferential and Premodulated Symptomatic relief of chronic, intractable pain Management of pain associated with post-traumatic or post-operative conditions

Source page: https://510kreport.com/device/K982324
Methodology: https://510kreport.com/methodology