510(k) · Cleared
ClearedTranscutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bozhou Rongjian Medical Appliance Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 25, 2022 as substantially equivalent to K202893 (Wuxi Jiajian Medical Instrument Co., Ltd., 2021) after an 86-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- May 25, 2022
- Review
- 86 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010782 (2001). 7 ancestors in all, the oldest K010665 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 4 generations backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- 3 generations backK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- 2 generations backK112288 Jiajian TensWuxi Jiajian Medical Instrument Co., Ltd. · 2012
- 1 generation backK202893 Transcutaneous Electrical Nerve StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021
- This deviceK220578 Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)Bozhou Rongjian Medical Appliance Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK222879 Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)Wuxi Jiajian Medical Instrument Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)Wuxi Jiajian Medical Instrument Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −4 | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| −3 | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007 | — |
| −2 | K112288 | Jiajian Tens | Wuxi Jiajian Medical Instrument Co., Ltd. | 2012 | — |
| −1 | K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021 | — |
| 0 (this device) | K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022 | — |
| +1 | K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K202893 | Transcutaneous Electrical Nerve StimulatorSummary page 4…ries of electrodes is 510(k) cleared device (K213879), Size: 50*50mm. 3. Predicate Device Identification Predicate 510(k) Number: K202893 Marketing clearance date: June 18, 2021 Product name: Transcutaneous Electrical Nerve Stimulator Manufact… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | 2023 | 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 21 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K222879 (Wuxi Jiajian Medical Instrument Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
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. 2022, 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?
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for
pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is
indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post
surgical and post traumatic pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220578: Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220578
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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