510(k) · Cleared

Cleared

Sonicator Plus 920

K111482510(k) SpecialCleared Aug 25, 201190-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 25, 2011 as substantially equivalent to K071137 (Mettler Electronics Corp., 2007) after a 90-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.

Decided: Aug 25, 2011
Review: 90 days
Class: Class II
Product code: IMG
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K984142 (1999). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
1 generation backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
This deviceK111482 Sonicator Plus 920Mettler Electronics Corp. · 2011
Descendant · cites it directly · 0 of its ownK182108 Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd. · 2019

Most influential descendants

Showing 1 of 1 · See all

K182108Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K984142	Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number…	Mettler Electronics Corp.	1999	—
−1	K071137	Sonicator Plus 940, Model ME940	Mettler Electronics Corp.	2007	—
0 (this device)	K111482	Sonicator Plus 920	Mettler Electronics Corp.	2011	—
+1	K182108	Portable Electro-Stimulation Therapy Device	Guangzhou Longest Science & Technology Co., Ltd.	2019	—

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
2019	1	0

FIG. 1 — Lineage of K111482, 1999–2019Source: 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

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What was it cleared against? (1)

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
*	K071137	Sonicator Plus 940, Model ME940 Summary page 2 …N NAME: Combination Ultrasound'and Muscle Stimulator Predicate Device: TRADE NAME: Sonicatort Plus 940, Model ME 940 510(k) Number: K071 137 Description of Proposed Device: The Sonicatoro Plus 920, Model ME 920 is a two-channel combination unit for therapeu…	Mettler Electronics Corp.	2007	—

Also cleared against K071137: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K182108	Portable Electro-Stimulation Therapy Device	Guangzhou Longest Science & Technology Co., Ltd.	2019	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?

The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 8.5 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K182108 (Guangzhou Longest Science & Technology Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K071137.

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. 2011, 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 (157 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 as stated in the FDA summary.

https://510kreport.com/device/K111482 · printed Nov 4, 2026

Cite this page

510(k) Report. “K111482: Sonicator Plus 920.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111482

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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