# K132284: Vectra Neo Clinical Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Djo, LLC
- Decided: Apr 10, 2014 after 261 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945509 (1995). 4 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040662: Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems, Chattanooga Group (2004) Summary page 2.
- K062354: Vectra Genisys VMS FR, Encore Medical L.P. (2007) Summary page 2.

## Most influential descendants
- K192249: InMode System with Tone Applicator (2019), 9 descendants of its own
- K201285: InMode Evolve System with the Tone Applicator (2021), 6 descendants of its own
- K210877: Evolve System with the T3 Applicator (2021), 5 descendants of its own
- K153696: Chattanooga Revolution Wireless (2016), 3 descendants of its own
- K241433: EVE Synergy (EVE-20M) (2025), 1 descendant of its own

## Indications for use
Vectra Neo Clinical Therapy System is indicated for: For VMS-(Pulsed Mode, Burst Mode or FR Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (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-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HANS * Symptomatic relief or management of chronic, intractable pain * Post-traumatic acute pain * Post-surgical acute pain For DC Continuous Mode * Relaxation of muscle spasm 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 EMG triggered Stim * Stroke rehab by muscle re-education * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increase local blood circulation * Muscle re-education * Maintaining or increasing range of motion For EMO * To determine the activation timing of muscles for: - Retraining of muscle activation - Coordinating of muscle activation * An indication of the force produced by muscle for control and maintenance of muscle contractions - Relaxation muscle training - Muscle re-education For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: - Relief of pain, muscle spasms and joint contractures - Relief of pain, muscle spasms and joint contractures that may be associated with - Adhesive capsulitis - Bursitis with slight calcification - Myositis - Soft tissue injuries - Shortened tendons due to past injuries and scar tissues - Relief of sub-chronic and chronic pain and joint contractures resulting from: - Capsular tightness - Capsular scarring For Infrared Lamp (laser) To provide topical heating for the following: * Temporary increase in local blood circulation * Temporary relief of minor muscle and joint aches, pains and stiffness * Relaxation of muscles * Temporary relief of muscle spasms * Temporary relief of minor pain and stiffness associated with arthritis

Source page: https://510kreport.com/device/K132284
Methodology: https://510kreport.com/methodology