510(k) · Cleared

Cleared

Sonicator Plus 940, Model ME940

K071137510(k) AbbreviatedCleared Aug 1, 200799-day reviewClass II21 CFR 890.5860

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

Mettler Electronics Corp. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Cleared on Aug 1, 2007 as substantially equivalent to K984142 (Mettler Electronics Corp., 1999) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 1999. 19 later devices descend from it.

Decided: Aug 1, 2007
Review: 99 days
Class: Class II
Product code: IMG
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K984142 (1999). 2 ancestors in all. 19 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
This deviceK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
Descendant · cites it directly · 15 of its ownK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
Descendant · 2 generations on · 8 of its ownK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
Descendant · 3 generations on · 6 of its ownK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
Descendant · 4 generations on · 5 of its ownK210021 Axon TherapyNeuralace Medical, Inc. · 2021
Descendant · 5 generations on · 3 of its ownK230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption…Tonica Elektronik A/S · 2023

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2010high 4 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 19 · See all

K093138MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003Shenzhen Dongdixin Technology Co., Ltd. · 2010 · cites it directly15descendants
K113010FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012 · 2 generations on8descendants
K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co., Ltd. · 2018 · 3 generations on6descendants
K210021Axon TherapyNeuralace Medical, Inc. · 2021 · 4 generations on5descendants
K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S · 2023 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K984142	Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number…	Mettler Electronics Corp.	1999	—
0 (this device)	K071137	Sonicator Plus 940, Model ME940	Mettler Electronics Corp.	2007	—
+1	K093138	MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and…	Shenzhen Dongdixin Technology Co., Ltd.	2010	1
+2	K113010	FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator	Famidoc Technology Co., Ltd.	2012	—
+3	K181688	R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator	Shenzhen Roundwhale Technology Co., Ltd.	2018	—
+4	K210021	Axon Therapy	Neuralace Medical, Inc.	2021	—
+5	K230014	MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100…	Tonica Elektronik A/S	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	1	0
2012	2	0
2017	1	0
2018	1	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2023	2	0
2024	2	0
2025	4	0

FIG. 1 — Lineage of K071137, 1999–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 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? (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	Applicant	Decided	Recalls
*	K984142	Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994 Summary page 2 …c. COMMON NAME: Combination Ultrasound and Muscle Stimulator Predicate Devices: a. TRADE NAME: Sonicator® Plus 994, Model ME 994 b. 510(k) Number: K984142 c. TRADE NAME: Chattanooga Vectra Genesis d. 510(k) Number: K03 1077 Description of Proposed Device: The So…	Mettler Electronics Corp.	1999	—
*	K031077	Vectra Epr System and Intelect Epr System Summary page 2 …ices: a. TRADE NAME: Sonicator® Plus 994, Model ME 994 b. 510(k) Number: K984142 c. TRADE NAME: Chattanooga Vectra Genesis d. 510(k) Number: K03 1077 Description of Proposed Device: The Sonicator® Plus 940, Model ME 940 is a four-channel combination unit for therap…	Chattanooga Group	2003	17

Also cleared against K984142: 2 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K093138	MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003	Shenzhen Dongdixin Technology Co., Ltd.	2010	15
K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10	Shenzhen Dongdixin Technology Co., Ltd.	2017	2
K111482	Sonicator Plus 920	Mettler Electronics Corp.	2011	1
K092627	CT2011 Sonicstimu Pain Relief Device	Shenzhen Dongdixin Technology Co., Ltd.	2010	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K093138 (Shenzhen Dongdixin Technology Co., Ltd., 2010) has gone furthest, with 15 descendants of its own.
2 other devices also cite its predicate K984142.

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. 2007, this device’s year, is highlighted.

FDA decisions per year · IMG

1in 2025

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IMG

226in 2011

2007high 226 (2011) · low 110 (2007)2026

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

Recalls per year · IMG

2in 2008

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	110	0	0
2008	0	—	2	37
2009	0	—	0	26
2010	1	—	0	6
2011	3	226	0	21
2012	2	—	0	6
2013	0	—	0	4
2014	0	—	0	3
2015	2	—	0	4
2016	1	—	0	7
2017	0	—	0	3
2018	0	—	0	0
2019	0	—	0	14
2020	0	—	0	10
2021	0	—	0	13
2022	0	—	0	14
2023	0	—	0	7
2024	0	—	0	5
2025	1	—	0	9
2026	0	—	0	—

What is it indicated for?

Therapeutic 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: * Adhesive capsulitis * Bursitis with slight calcification * Myositis * Soft tissue injuries * Shortened tendons due to past injuries and scar tissues 3. Relief of pain…

Read the full statement (156 words)

Therapeutic 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:

* Adhesive capsulitis

* Bursitis with slight calcification

* Myositis

* Soft tissue injuries

* Shortened tendons due to past injuries and scar tissues

3. Relief of pain, muscle spasms and joint contractures resulting from:

* Capsular tightness

* Capsular tightening

4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms

1. Symptomatic relief of chronic intractable pain

2. Post-traumatic pain

3. Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms

1.Relaxation of muscle spasms

2. Increase local blood circulation

3. Prevention or retardation of disuse atrophy

4. Muscle re-education

5. Maintaining or increasing range of motion

6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

DC (Direct Current)

Relaxation of muscle spasms

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/K071137 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071137: Sonicator Plus 940, Model ME940.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071137

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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