510(k) · Cleared
ClearedDigital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instruments Co.,Ltd · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Oct 31, 2002 as substantially equivalent to K010782 (Transamerica Medical Systems, 2001) after a 238-day review. Its family tree reaches back 1 generation to 2001. 15 later devices descend from it.
- Decided
- Oct 31, 2002
- Review
- 238 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010782 (2001). 15 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010782 Transamerican TensTransamerica Medical Systems · 2001
- This deviceK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- Descendant · cites it directly · 14 of its ownK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- Descendant · 2 generations on · 6 of its ownK082514 Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008
- Descendant · 3 generations on · 4 of its ownK100117 LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems…Shenzhen Dongdixin Technology Co., Ltd. · 2010
- Descendant · 2 generations on · 3 of its ownK112288 Jiajian TensWuxi Jiajian Medical Instrument Co., Ltd. · 2012
- Descendant · 4 generations on · 3 of its ownK102014 Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K071951Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007 · cites it directly14descendants
- K082514Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008 · 2 generations on6descendants
- K100117LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems StimulatorShenzhen Dongdixin Technology Co., Ltd. · 2010 · 3 generations on4descendants
- K112288Jiajian TensWuxi Jiajian Medical Instrument Co., Ltd. · 2012 · 2 generations on3descendants
- K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| 0 (this device) | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| +1 | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007 | — |
| +2 | K082514 | Tens/Ems Combo, Ems, Tens | Medihightec Medical Co., Ltd. | 2008 | — |
| +3 | K100117 | LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | — |
| +2 | K112288 | Jiajian Tens | Wuxi Jiajian Medical Instrument Co., Ltd. | 2012 | — |
| +4 | K102014 | Tens Stimulator, Models 2800 and 3000 | Koalaty Products, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K010782 | Transamerican TensSummary page 2…19-Summary comparing technological characteristics with other predicate device: IFDA file reference number I 510k #k010782 1 Attachments inside notification submission file I TECHNOLOGICAL CHARACTERISTICS II 5 10k summary print o… | 2001 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K071951 (Everyway Medical Instruments Co.,Ltd, 2007) has gone furthest, with 14 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.
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?
EV-803 Digital TENS 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 and management of chronic (long term) intractable pain
- Adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020749: Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020749
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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