510(k) · Cleared
ClearedVectra Genisys VMS FR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · IPF Stimulator, Muscle, Powered
Cleared on Jan 26, 2007 as substantially equivalent to K945509 (Fx-2, 1995) and 1 other predicate after a 165-day review. Its family tree reaches back 1 generation to 1995. 21 later devices descend from it.
- Decided
- Jan 26, 2007
- Review
- 165 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945509 (1995). 2 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK945509 FX-2 NMS (2CHANNEL Table Model)Fx-2 · 1995
- This deviceK062354 Vectra Genisys VMS FREncore Medical L.P. · 2007
- Descendant · cites it directly · 14 of its ownK132284 Vectra Neo Clinical Therapy SystemDjo, LLC · 2014
- Descendant · 2 generations on · 9 of its ownK192249 InMode System with Tone ApplicatorInMode, Ltd. · 2019
- Descendant · 3 generations on · 6 of its ownK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- Descendant · 4 generations on · 5 of its ownK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK153696 Chattanooga Revolution WirelessDjo, LLC · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K132284Vectra Neo Clinical Therapy SystemDjo, LLC · 2014 · cites it directly14descendants
- K192249InMode System with Tone ApplicatorInMode, Ltd. · 2019 · 2 generations on9descendants
- K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021 · 3 generations on6descendants
- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · 4 generations on5descendants
- K153696Chattanooga Revolution WirelessDjo, LLC · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945509 | FX-2 NMS (2CHANNEL Table Model) | Fx-2 | 1995 | — |
| 0 (this device) | K062354 | Vectra Genisys VMS FR | Encore Medical L.P. | 2007 | — |
| +1 | K132284 | Vectra Neo Clinical Therapy System | Djo, LLC | 2014 | — |
| +2 | K192249 | InMode System with Tone Applicator | InMode, Ltd. | 2019 | — |
| +3 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +4 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +2 | K153696 | Chattanooga Revolution Wireless | Djo, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IPF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945509 | FX-2 NMS (2CHANNEL Table Model)Summary page 1…onal neuromuscular stimulator 2] CFR 876.5320- Non-implantable electrical continence device 89- Physical Medicine, 84- Neurology & 78- Gastroenterology Omnistim FX® — K945509 Omnistim FX2 Pro — K945508 Page 1 of 3 Summary - 510(k) # K062354 Description: Vectra Genisys electrotherapy pr… | 1995 |
| * | K945508 | FX-2P NMS (2 Channel Portable)Summary page 1…or 2] CFR 876.5320- Non-implantable electrical continence device 89- Physical Medicine, 84- Neurology & 78- Gastroenterology Omnistim FX® — K945509 Omnistim FX2 Pro — K945508 Page 1 of 3 Summary - 510(k) # K062354 Description: Vectra Genisys electrotherapy product lines offer clinician… | 1995 |
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K132284 (Djo, LLC, 2014) has gone furthest, with 14 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
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…
Read the full statement (273 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062354: Vectra Genisys VMS FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062354
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026