# K062354: Vectra Genisys VMS FR

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jan 26, 2007 after 165 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: 1 generation back to K945509 (1995). 2 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945509: FX-2 NMS (2CHANNEL Table Model), Fx-2 (1995) Summary page 1.
- K945508: FX-2P NMS (2 Channel Portable), Fx-2 (1995) Summary page 1.

## Most influential descendants
- K132284: Vectra Neo Clinical Therapy System (2014), 14 descendants of its own
- 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

## Indications for use
For VMS-(Pulsed Mode, Burst Mode or FR Mode), Russian, Moenophasic 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 Bipbasic (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 Coutinucus Mode Relaxation of muscle spasm For EMG To determination the activation timing of muscles for: a) retraining of muscle activation b) coordination 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 EMG triggered Stim Stroke rehab by muscle re-education Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increase Jocal blood circulation Muscle re-education Maintaining or increasing range of motion 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 ¢) 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) Cepsular scarring

Source page: https://510kreport.com/device/K062354
Methodology: https://510kreport.com/methodology