510(k) · Cleared
ClearedComfy Series: EV-804, EV-805 & EV-806
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 Sep 5, 2007 as substantially equivalent to K020749 (Everyway Medical Instruments Co.,Ltd, 2002) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 2001. 14 later devices descend from it.
- Decided
- Sep 5, 2007
- Review
- 51 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010782 (2001). 4 ancestors in all, the oldest K010665 (2001). 14 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 1 generation backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- This deviceK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- Descendant · cites it directly · 6 of its ownK082514 Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008
- Descendant · 2 generations on · 4 of its ownK100117 LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems…Shenzhen Dongdixin Technology Co., Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK112288 Jiajian TensWuxi Jiajian Medical Instrument Co., Ltd. · 2012
- Descendant · 3 generations on · 3 of its ownK102014 Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK202893 Transcutaneous Electrical Nerve StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K082514Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008 · cites it directly6descendants
- K100117LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems StimulatorShenzhen Dongdixin Technology Co., Ltd. · 2010 · 2 generations on4descendants
- K112288Jiajian TensWuxi Jiajian Medical Instrument Co., Ltd. · 2012 · cites it directly3descendants
- K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010 · 3 generations on3descendants
- K202893Transcutaneous Electrical Nerve StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −1 | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| 0 (this device) | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007 | — |
| +1 | K082514 | Tens/Ems Combo, Ems, Tens | Medihightec Medical Co., Ltd. | 2008 | — |
| +2 | K100117 | LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | — |
| +1 | K112288 | Jiajian Tens | Wuxi Jiajian Medical Instrument Co., Ltd. | 2012 | — |
| +3 | K102014 | Tens Stimulator, Models 2800 and 3000 | Koalaty Products, Inc. | 2010 | — |
| +2 | K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital TensSummary page 1…l Equivalency is claimed against the following device: * Digital TENS, model EV-803 from Everyway Medical Instruments Co., Ltd. 510k# K020749 * Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd. 510k# K020750 16-De… | 2002 |
| * | K020750 | Digital Electrical Muscle Stimulator, Model EV-807 Digital EmsSummary page 1…Instruments Co., Ltd. 510k# K020749 * Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd. 510k# K020750 16-Description of the Device: The Comfy Series, which includes models EV-804, EV-805, EV-806, are Transcutaneous Electrical Ner… | 2002 |
What descends from it? (14)
See all 143 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K082514 (Medihightec Medical Co., Ltd., 2008) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K020749.
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. 2007, 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?
APPLICABLE FOR EV-804 (TENS) AND EV-806 (TENS/EMS COMBINATION UNIT): This device 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 (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems…
Read the full statement (155 words)
APPLICABLE FOR EV-804 (TENS) AND EV-806 (TENS/EMS COMBINATION UNIT):
This device 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 (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
APPLICABLE FOR EV-805 (EMS) AND EV-806 (TENS/EMS COMBINATION UNIT):
This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071951: Comfy Series: EV-804, EV-805 & EV-806.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071951
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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