510(k) · Cleared
ClearedTens Stimulator, Models 2800 and 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koalaty Products, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 31, 2010 as substantially equivalent to K100117 (Shenzhen Dongdixin Technology Co., Ltd., 2010) after a 46-day review. Its family tree reaches back 5 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 31, 2010
- Review
- 46 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). 3 later devices descend from it, 2 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 backK082514 Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008
- 1 generation backK100117 LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems…Shenzhen Dongdixin Technology Co., Ltd. · 2010
- This deviceK102014 Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK133779 CP Relief WandMid-America Medical Innovations, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
- Descendant · cites it directly · 0 of its ownK113544 Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation · 2012
Most influential descendants
Showing 3 of 3 · See all- K133779CP Relief WandMid-America Medical Innovations, LLC · 2014 · cites it directly1descendant
- K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025 · 2 generations on0descendants
- K113544Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation · 2012 · 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 | 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 | — |
| 0 (this device) | K102014 | Tens Stimulator, Models 2800 and 3000 | Koalaty Products, Inc. | 2010 | — |
| +1 | K133779 | CP Relief Wand | Mid-America Medical Innovations, LLC | 2014 | — |
| +2 | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K100117 | LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems StimulatorSummary page 2…Device Class: 1I 2. Predicate Device: Predicate Device: LT3001 TENS Stimulator 510(k)Number: K(100117 Manufacturer: Shenzhen Dongdixin Technology Co., Ltd. 3. Description of Proposed Device: TENS S… | 2010 |
What descends from it? (3)
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 9 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K133779 (Mid-America Medical Innovations, LLC, 2014) has gone furthest, with 1 descendant 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. 2010, 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?
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102014 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102014: Tens Stimulator, Models 2800 and 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102014
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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