510(k) · Cleared
ClearedHivox Electric Stimulator Tens & Ems, HD2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hivox Biotek, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Mar 30, 2010 as substantially equivalent to K082514 (Medihightec Medical Co., Ltd., 2008) after a 232-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 30, 2010
- Review
- 232 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010782 (2001). 6 ancestors in all, the oldest K010665 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 3 generations backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- 2 generations backK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- 1 generation backK082514 Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008
- This deviceK092448 Hivox Electric Stimulator Tens & Ems, HD2Hivox Biotek, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −3 | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K092448 | Hivox Electric Stimulator Tens & Ems, HD2 | Hivox Biotek, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K082514 | Tens/Ems Combo, Ems, TensSummary page 1…ECONDARY IPF, Class II, 890.5850 PRODUCT CODE: PREDICATED MEDIHIGHTEC Medical Co., Ltd. DEVICE: TENS/EMS Combo, EMS, TENS K0825 14 0D7 HIT-OX BIOTEK INC H IV… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K082514.
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?
The TENS programs of HIVQX Electric Stimulator TENS & EMS, HD2: The 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 of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems. The EMS programs…
Read the full statement (153 words)
The TENS programs of HIVQX Electric Stimulator TENS & EMS, HD2:
The 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 of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems.
The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2:
The device is an electrical powered muscle stimulator indicated for medical purpose 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/K092448 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092448: Hivox Electric Stimulator Tens & Ems, HD2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092448
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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