510(k) · Cleared

Cleared

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

K231423510(k) TraditionalCleared Jan 22, 2024250-day reviewClass II21 CFR 882.5890

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. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

Cleared on Jan 22, 2024 as substantially equivalent to K192087 (Shenzhen Roundwhale Technology Co., Ltd., 2019) after a 250-day review. Its family tree reaches back 1 generation to 2019.

Decided: Jan 22, 2024
Review: 250 days
Class: Class II
Product code: NUH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K192087 (2019). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK192087 Combo Electrotherapy DeviceShenzhen Roundwhale Technology Co., Ltd. · 2019
This deviceK231423 Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F…Shenzhen Roundwhale Technology Co., Ltd. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K192087	Combo Electrotherapy Device	Shenzhen Roundwhale Technology Co., Ltd.	2019	—
0 (this device)	K231423	Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100…	Shenzhen Roundwhale Technology Co., Ltd.	2024	—

FIG. 1 — Lineage of K231423, 2019–2024Source: 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 NUH? 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 NUH device

#1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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
*	K192087	Combo Electrotherapy Device Summary page 8 …dicate Device: Primary predicate device 510(K) Trade or Proprietary or Model Manufacturer Product Code Name K192087 Combo Electrotherapy Device Shenzhen Roundwhale Technology Co., Ltd. NUH,GZJ,IPF,NGX Reference Predicate device 51…	Shenzhen Roundwhale Technology Co., Ltd.	2019	—
†	K181688	R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator	Shenzhen Roundwhale Technology Co., Ltd.	2018	—
†	K180956	Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator…	Shenzhen Roundwhale Technology Co., Ltd.	2018	—

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?

Its one ancestor has no recall.

How does its category compare?

All NUH devices

NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NUH

15in 2025

2007high 20 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUH

119in 2025

2007high 231 (2011) · low 90 (2024)2026

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

Recalls per year · NUH

No recall names NUH since 2007.

Adverse event reports per year · NUH

7in 2025

2007high 21 (2017) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	4	161	0
2008	0	—	0
2009	1	—	0
2010	3	148	0
2011	6	231	0
2012	6	170	0
2013	10	189	1
2014	16	212	9
2015	14	198	11
2016	13	145	13
2017	17	155	21
2018	16	121	18
2019	19	213	5
2020	14	147	8
2021	14	198	7
2022	20	103	2
2023	15	127	4
2024	20	90	7
2025	15	119	7
2026	5	137	—

What is it indicated for?

Over-The-Counter Use: a. Model R-C101C is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. b. Model…

Read the full statement (804 words)

Over-The-Counter Use:

a. Model R-C101C is indicated for OTC TENS and OTC EMS.

OTC TENS(NUH)

It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

OTC EMS(NGX)

This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

b. Model R-C101D is indicated for OTC TENS.

c. Model R-C101F is indicated for OTC TENS and OTC EMS.

OTC TENS(NUH)

OTC EMS(NGX)

This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

d. Model R-C101G is indicated for OTC TENS and OTC EMS.

OTC TENS(NUH)

OTC EMS(NGX)

This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

e. Model F100 is indicated for OTC TENS and OTC EMS.

OTC TENS(NUH)

OTC EMS(NGX)

This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

f. Model MINI-TENS-COMB is indicated for OTC TENS.

OTC TENS(NUH)

g. Model R-C101I is indicated for OTC TENS.

OTC TENS(NUH)

h. Model TENS3500 is indicated for OTC TENS.

OTC TENS(NUH)

Prescription Use:

a. Model R-C101D is indicated for Rx TENS.

Rx TENS(GZJ)

1)Symptomatic relief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

b. Model R-C101G is indicated for Rx TENS and Rx EMS.

Rx TENS(GZJ)

1)Symptomatic relief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

Rx EMS(IPF):

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 calf muscles to prevent venous thrombosis.

c. Model R-C101C, is indicated for Rx TENS and Rx EMS.

Rx TENS(GZJ) :

1)Symptomatic rlief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

Rx EMS(IPF):

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 calf muscles to prevent venous thrombosis.

d. Model F100 is indicated for Rx TENS and Rx EMS.

Rx TENS(GZJ) :

1)Symptomatic relief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

Rx EMS(IPF):

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 calf muscles to prevent venous thrombosis.

e. Model MINI-TENS-COMB is indicated for Rx TENS.

Rx TENS(GZJ) :

1)Symptomatic relief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

f. Model R-C101F is indicated for Rx TENS and Rx EMS.

Rx TENS(GZJ) :

1)Symptomatic relief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

Rx EMS(IPF):

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 calf muscles to prevent venous thrombosis.

g. Model R-C101I is indicated for Rx TENS.

Rx TENS(GZJ) :

1)Symptomatic relief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

h. Model TENS3500 is indicated for Rx TENS.

Rx TENS(GZJ) :

1)Symptomatic relief of chronic intractable pain;

2)Post traumatic pain;

3)Post surgical pain;

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/K231423 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231423: Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231423

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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 (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

Line of descent and top descendants

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?

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