510(k) Report

510(k) · Cleared

Recalled · 2008

Vectra Epr System and Intelect Epr System

K031077510(k) TraditionalCleared Dec 11, 2003251-day reviewClass II21 CFR 890.5860Recalls 17

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Chattanooga Group · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Cleared on Dec 11, 2003 after a 251-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 73 later devices descend from it. It has been recalled 17 times.

Decided
Dec 11, 2003
Review
251 days
Class
Class II
Product code
IMG
Recalls
17
Predicates
0

73 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2012: 5 descendants cleared2007: 3 descendants cleared2013: 3 descendants cleared2021: 4 descendants cleared2015: 1 descendant cleared2010: 2 descendants cleared2017: 3 descendants cleared2011: 1 descendant cleared2009: 1 descendant cleared2023: 8 descendants cleared2016: 2 descendants cleared2014: 2 descendants cleared2019: 5 descendants cleared2020: 7 descendants cleared2024: 6 descendants cleared2022: 4 descendants cleared2026: 4 descendants cleared2018: 1 descendant cleared2025: 11 descendants cleared200020052010201520202025
  1. This deviceK031077 Vectra Epr System and Intelect Epr SystemChattanooga Group · 2003
  2. Descendant · cites it directly · 29 of its ownK071431 Globus Genesy 1100 StimulatorDomino S.R.L. · 2007
  3. Descendant · 2 generations on · 28 of its ownK090632 Compex RehabChattanooga Group · 2009
  4. Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
  5. Descendant · 4 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
  6. Descendant · cites it directly · 19 of its ownK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2007: 32009: 12010: 22011: 12012: 52013: 32014: 22015: 12016: 22017: 32018: 12019: 52020: 72021: 42022: 42023: 82024: 62025: 112026: 4
2007high 11 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 73 · See all
  • K071431Globus Genesy 1100 StimulatorDomino S.R.L. · 2007 · cites it directly29descendants
  • K090632Compex RehabChattanooga Group · 2009 · 2 generations on28descendants
  • K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
  • K153704StriveDjo, LLC · 2016 · 4 generations on24descendants
  • K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007 · cites it directly19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031077Vectra Epr System and Intelect Epr SystemChattanooga Group2003—
+1K071431Globus Genesy 1100 StimulatorDomino S.R.L.2007—
+2K090632Compex RehabChattanooga Group2009—
+3K124016Empi PhoenixDjo, LLC2013—
+4K153704StriveDjo, LLC2016—
+1K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200910
201020
201110
201250
201330
201420
201510
201620
201730
201810
201950
202070
202140
202240
202380
202460
2025110
202640
FIG. 1 — Lineage of K031077, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IMG? 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 IMG device

  1. #1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (73)

See all 73

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071431Globus Genesy 1100 StimulatorDomino S.R.L.200729
K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp.200719
K113017Sys*Stim 240Mettler Electronics Corp.20129
K121369Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle StimulatorIbramed Equipamentos Medicos20125
K121059Soleoline, Soleo Stim, Soleo Sono, Soleo SonostimZimmer Medizinsystems GmbH20124
K131629Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos20131
K210572Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos20210
K150353BTL-4000BTL Industries, Inc.20150
K063135Sonic-StimNaimco, Inc.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 28, 2008Not classifiedZ-1637-2008Component design/selectionDevice may fail to administer therapy during use.
Feb 28, 2008Not classifiedZ-1638-2008Component design/selectionDevice may fail to administer therapy during use.
Dec 17, 2007Not classifiedZ-1227-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1229-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1231-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1218-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1230-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1223-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1226-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1221-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1220-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1222-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1225-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1232-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1228-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1219-2008Device DesignDevice malfunction: causing electric shock and burn.
Dec 17, 2007Not classifiedZ-1224-2008Device DesignDevices have the potential to electric shock and burn

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K071431 (Domino S.R.L., 2007) has gone furthest, with 29 descendants of its own.

How does its category compare?

All IMG devices

IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IMG

1in 2025

2007: 32010: 12011: 32012: 22015: 22016: 12025: 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IMG

226in 2011

2007: 110 days median2011: 226 days median
2007high 226 (2011) · low 110 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IMG

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IMG

9in 2025

2008: 372009: 262010: 62011: 212012: 62013: 42014: 32015: 42016: 72017: 32019: 142020: 102021: 132022: 142023: 72024: 52025: 9
2007high 37 (2008) · low 0 (2007)2025

MAUDE reports naming product code IMG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007311000
20080—237
20090—026
20101—06
20113226021
20122—06
20130—04
20140—03
20152—04
20161—07
20170—03
20180—00
20190—014
20200—010
20210—013
20220—014
20230—07
20240—05
20251—09
20260—0—

What is it indicated for?

For VMS, VMS Burst, 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, VMS Burst, Asymmetrical Biphasic (TENS)…

Read the full statement (265 words)

For VMS, VMS Burst, 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, VMS Burst, Asymmetrical Biphasic (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 Continuous 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 local 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

c) 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) Capsular scarring

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Chattanooga Group

11 FDA decisions under this applicant name. See the company

  • K090632Compex RehabChattanooga Group · 2009
  • K083433Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Chattanooga Group · 20091 recall
  • K083140Compex Sport PlusChattanooga Group · 2009
  • K070425Vitalstim ExperiaChattanooga Group · 2007
  • K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006

Recent decisions in IMG

The IMG category page

  • K244041Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd. · 2025
  • K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp) · 2016
  • K150353BTL-4000BTL Industries, Inc. · 2015
  • K150436ComboRehabShenzhen Dongdixin Technology Co., Ltd. · 2015
  • K120217Sonicstimu Combo Therapeutic DeviceShenzhen Dongdixin Technology Co., Ltd. · 2012

https://510kreport.com/device/K031077 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031077: Vectra Epr System and Intelect Epr System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031077

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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