510(k) · Cleared

Cleared

Combo Electrotherapy Device

K231440510(k) TraditionalCleared Nov 3, 2023169-day reviewClass II21 CFR 890.5850

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

Shenzhen Roundwhale Technology Co., Ltd. · IPF Stimulator, Muscle, Powered

Cleared on Nov 3, 2023 as substantially equivalent to K171978 (Shenzhen Dongdixin Technology Co., Ltd., 2017) after a 169-day review. Its family tree reaches back 4 generations to 1999.

Decided: Nov 3, 2023
Review: 169 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K984142 (1999). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
3 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
2 generations backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
1 generation backK171978 Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator…Shenzhen Dongdixin Technology Co., Ltd. · 2017
This deviceK231440 Combo Electrotherapy DeviceShenzhen Roundwhale Technology Co., Ltd. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K984142	Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number…	Mettler Electronics Corp.	1999	—
−3	K071137	Sonicator Plus 940, Model ME940	Mettler Electronics Corp.	2007	—
−2	K093138	MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and…	Shenzhen Dongdixin Technology Co., Ltd.	2010	1
−1	K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10	Shenzhen Dongdixin Technology Co., Ltd.	2017	—
0 (this device)	K231440	Combo Electrotherapy Device	Shenzhen Roundwhale Technology Co., Ltd.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K231440, 1999–2023Source: 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 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

Get a 510(k) Report

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
*	K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 Summary page 7 …Predicate Device: 510(K) Trade or Proprietary or Model Name Manufacturer Product Code K171978 Combo Stimulator LT7102 Shenzhen Dongdixin Technology Co., Ltd. IPF,ZJ, LIH 4. Description…	Shenzhen Dongdixin Technology Co., Ltd.	2017	—
†	K222252	Self-adhesive Electrode	Shenzhen Roundwhale Technology Co., Ltd.	2023	—

Also cleared against K171978: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
2 of the 5 ancestors have a recall of any class.
1 other device also cites its predicate K171978.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · IPF

3in 2025

2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IPF

8in 2025

2007high 213 (2008) · low 2 (2017)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?

Model:R-C101W: For TENS/IF/MIC mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For EMS/RUSS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow 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 muscles to prevent venous thrombosis Model:R-C101A For TENS/IF mode 1)…

Read the full statement (341 words)

Model:R-C101W:

For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain

2. Post traumatic pain

3. Post surgical pain

For EMS/RUSS mode

1. Relaxation of muscle spasm.

2. Increase of local blood flow 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 muscles to prevent venous thrombosis

Model:R-C101A

For TENS/IF mode

1) Symptomatic relief of chronic intractable pain.

2) Post traumatic pain.

3) Post surgical pain.

For EMS/RUSS mode

1) Relaxation of muscle spasm.

2) Increase of blood flow 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 muscles to prevent venous thrombosis

Model:R-C101B

For TENS/IF mode

1. Symptomatic relief of chronic intractable pain

2. Post traumatic pain

3. Post surgical pain

For EMS/RUSS mode

1. Relaxation of muscle spasm.

2. Increase of local blood flow 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 muscles to preventvenous thrombosis

Model:R-C101E

For IF mode

1. Symptomatic relief of chronic intractable pain

2. Post traumatic pain

3. Post surgical pain

For RUSS mode

1. Relaxation of muscle spasm.

2. Increase of local blood flow 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 muscles to preventvenous thrombosis

Model:R-C101H

For TENS and IF mode

1) Symptomatic relief of chronic intractable pain.

2) Post traumatic pain.

3) Post surgical pain.

Model:R-C101D

For TENS mode

1. Symptomatic relief of chronic intractable pain

2. Post traumatic pain

3. Post surgical pain

Model:R-C101G

For TENS mode

1) Symptomatic relief of chronic intractable pain.

2) Post traumatic pain.

3) Post surgical pain.

For EMS mode

1. Relaxation of muscle spasm.

2. Increase of local blood flow 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 muscles to preventvenous thrombosis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231440 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231440: Combo Electrotherapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231440

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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

Combo Electrotherapy Device

Line of descent and top descendants

Other ancestors by year cleared

What was it cleared against? (1)

What descends from it?

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

What does this lineage say?

How does its category compare?

What is it indicated for?

Also cleared against K171978

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