510(k) · Cleared
ClearedOGYILI TENS/NMES Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gongguan Tutamen Metalwork Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Nov 9, 2020 as substantially equivalent to K193275 (Shenzhen Xft Medical Limited, 2020) after a 161-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Nov 9, 2020
- Review
- 161 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K912178 (1991). 19 ancestors in all, the oldest K880042 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 6 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 5 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 4 generations backK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- 3 generations backK070299 Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007
- 2 generations backK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- 1 generation backK193275 Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2020
- This deviceK201431 OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −6 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −5 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −4 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| −3 | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007 | — |
| −2 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| −1 | K193275 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020 | — |
| 0 (this device) | K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K193275 | Nerve and Muscle StimulatorSummary page 4…nce: None 5.5 Predicate Device Information: The “OGYILI TENS/NMES Stimulator E01” described in this premarket notification is substantially equivalent to: (1) K193275, “Nerve and Muscle Stimulator (model: XFT-2000)”, Manufactured by “Shenzhen XFT Medical Limited” Reference Device: (2)… | 2020 |
| † | K092990 | Amd 6605 Tens/Nmes | 2009 |
| † | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | 2017 |
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 29 years and passes through 8 companies; a new generation was cleared every 3.5 years on median.
- None of the 19 ancestors has a recall.
- 1 other device also cites its predicate K193275.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
TENS function of the device is indicated for the following use:
Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain
NMES function of the device is indicated for the following use:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201431: OGYILI TENS/NMES Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201431
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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