510(k) · Cleared
ClearedTens/Ems Combo, Ems, Tens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medihightec Medical Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Oct 21, 2008 as substantially equivalent to K071951 (Everyway Medical Instruments Co.,Ltd, 2007) after a 49-day review. Its family tree reaches back 3 generations to 2001. 6 later devices descend from it.
- Decided
- Oct 21, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010782 (2001). 5 ancestors in all, the oldest K010665 (2001). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 2 generations backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- 1 generation backK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- This deviceK082514 Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008
- Descendant · cites it directly · 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 ownK102014 Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK133779 CP Relief WandMid-America Medical Innovations, LLC · 2014
- Descendant · 4 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK113544 Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100117LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems StimulatorShenzhen Dongdixin Technology Co., Ltd. · 2010 · cites it directly4descendants
- K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010 · 2 generations on3descendants
- K133779CP Relief WandMid-America Medical Innovations, LLC · 2014 · 3 generations on1descendant
- K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025 · 4 generations on0descendants
- K113544Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K082514 | Tens/Ems Combo, Ems, Tens | Medihightec Medical Co., Ltd. | 2008 | — |
| +1 | K100117 | LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | — |
| +2 | K102014 | Tens Stimulator, Models 2800 and 3000 | Koalaty Products, Inc. | 2010 | — |
| +3 | K133779 | CP Relief Wand | Mid-America Medical Innovations, LLC | 2014 | — |
| +4 | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 | — |
| +3 | K113544 | Electronic Pulse Massager Tens Electronic Pulse Massager | Prospera Corporation | 2012 | — |
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 |
|---|---|---|
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K071951 | Comfy Series: EV-804, EV-805 & EV-806Summary page 1…device: (a) The new device MH8000 and MH6000 compared to the predicate devices: Comfy STIM, model EV-806 from Everyway Medical instruments Co., Ltd. 51 Ok# K071951, Product Code: GZJ; IPF. (b) The new device MH8 100 and MH6 100 compared to the predicate devices: Comfy EMS, model EV-80… | 2007 |
What descends from it? (6)
2 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 7 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K100117 (Shenzhen Dongdixin Technology Co., Ltd., 2010) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K071951.
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. 2008, 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 MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8200 (TENS) AND MH6200 (TENS): 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…
Read the full statement (171 words)
APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8200 (TENS) AND MH6200 (TENS):
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 MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8l00 (EMS) AND MH6l00 (EMS):
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/K082514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082514: Tens/Ems Combo, Ems, Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082514
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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