510(k) · Cleared
ClearedVectra Neo Clinical Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo, LLC · IPF Stimulator, Muscle, Powered
Cleared on Apr 10, 2014 as substantially equivalent to K040662 (Chattanooga Group, 2004) and 1 other predicate after a 261-day review. Its family tree reaches back 2 generations to 1995. 14 later devices descend from it.
- Decided
- Apr 10, 2014
- Review
- 261 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945509 (1995). 4 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945509 FX-2 NMS (2CHANNEL Table Model)Fx-2 · 1995
- 1 generation backK062354 Vectra Genisys VMS FREncore Medical L.P. · 2007
- This deviceK132284 Vectra Neo Clinical Therapy SystemDjo, LLC · 2014
- Descendant · cites it directly · 9 of its ownK192249 InMode System with Tone ApplicatorInMode, Ltd. · 2019
- Descendant · 2 generations on · 6 of its ownK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- Descendant · 3 generations on · 5 of its ownK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK153696 Chattanooga Revolution WirelessDjo, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK241433 EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K192249InMode System with Tone ApplicatorInMode, Ltd. · 2019 · cites it directly9descendants
- K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021 · 2 generations on6descendants
- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · 3 generations on5descendants
- K153696Chattanooga Revolution WirelessDjo, LLC · 2016 · cites it directly3descendants
- K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945509 | FX-2 NMS (2CHANNEL Table Model) | Fx-2 | 1995 | — |
| −1 | K062354 | Vectra Genisys VMS FR | Encore Medical L.P. | 2007 | — |
| 0 (this device) | K132284 | Vectra Neo Clinical Therapy System | Djo, LLC | 2014 | — |
| +1 | K192249 | InMode System with Tone Applicator | InMode, Ltd. | 2019 | — |
| +2 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +3 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +1 | K153696 | Chattanooga Revolution Wireless | Djo, LLC | 2016 | — |
| +3 | K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…Summary page 2…84 -Neurology Predicate Device(s): Vectra Genisys Laser System (Intelect XT Laser System) (K040662) Vectra Genisys (K062354) Device Description: The Vectra Neo, Cl… | 2004 |
| * | K062354 | Vectra Genisys VMS FRSummary page 2…Genisys Laser System (Intelect XT Laser System) (K040662) Vectra Genisys (K062354) Device Description: The Vectra Neo, Clinical Therapy System isan electrotherapy product offering clinicians a… | 2007 |
| † | K900519 | Classic Ecg/Stimulating NO. 1700 Series | 1990 |
| † | K874469 | Transcutaneous Electric Nerve Stimulation (Tens) | 1988 |
| † | K852267 | Electrical Nerve Stimulation (Tens) Electrodes | 1985 |
| † | K970426 | Valuetrode | 1997 |
| † | K955246 | Ecogel 200 Ultrasound Gel | 1996 |
What descends from it? (14)
See all 142 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192249 (InMode, Ltd., 2019) has gone furthest, with 9 descendants of its own.
- 9 other devices also cite its predicate K040662.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
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…
Read the full statement (354 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132284 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132284: Vectra Neo Clinical Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132284
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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