510(k) · Cleared

Cleared

Tyece OTC TENS Model

K200838510(k) TraditionalCleared Aug 12, 2020134-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

Tyece Limited · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

Cleared on Aug 12, 2020 as substantially equivalent to K130802 (Shenzhen Dongdixin Technology Co., Ltd., 2013) after a 134-day review. Its family tree reaches back 1 generation to 2013.

Decided: Aug 12, 2020
Review: 134 days
Class: Class II
Product code: NUH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K130802 (2013). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
This deviceK200838 Tyece OTC TENS ModelTyece Limited · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K130802	Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)	Shenzhen Dongdixin Technology Co., Ltd.	2013	—
0 (this device)	K200838	Tyece OTC TENS Model	Tyece Limited	2020	—

FIG. 1 — Lineage of K200838, 2013–2020Source: 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

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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
*	K130802	Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) Summary page 4 …Pain Relief Product code: NUH Regulation class: II Regulation Number: 21 CFR 882.5890 3. Predicate Device Trade/Device Name: LT3060 510(k) Number: K130802 4. Reference Device Trade/Device Name: Savia OTC TENS Model EM-38 510(k) Number: K113321 5. Device Description: T…	Shenzhen Dongdixin Technology Co., Ltd.	2013	—
†	K113321	Tens Back Pain Relief System	Savia Limited	2012	—

Also cleared against K130802: 6 other devices →

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.
6 other devices also cite its predicate K130802.

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. 2020, 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?

The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work…

Read the full statement (164 words)

The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

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/K200838 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200838: Tyece OTC TENS Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200838

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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