510(k) · Cleared
ClearedNT2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 27, 1998 as substantially equivalent to K912178 (Skylark Device Co., Ltd., 1991) after a 256-day review. Its family tree reaches back 1 generation to 1991. 80 later devices descend from it.
- Decided
- Feb 27, 1998
- Review
- 256 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912178 (1991). 80 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- This deviceK972244 NT2000Bio-Medical Research, Ltd. · 1998
- Descendant · cites it directly · 78 of its ownK990787 TRIO 300Ito Co., Ltd. · 1999
- Descendant · 2 generations on · 63 of its ownK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- Descendant · 3 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · 3 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- Descendant · 4 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K990787TRIO 300Ito Co., Ltd. · 1999 · cites it directly78descendants
- K023231Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003 · 2 generations on63descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 3 generations on35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 3 generations on34descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 4 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| 0 (this device) | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| +1 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| +2 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| +3 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +3 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| +4 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 9 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K912178 | Bio Tens 601, 606 and 608 (3000)Summary page 1…irs Manager 6™ June, 1997 NT2000 TENS Transcutaneous Electrical Nerve Stimulator for pain relief, §882.5890 Bio Tens Model: ST-601 (Skylark Device Co. Ltd., 510(k) # K912178) 510(k) Premarket Notification for NT2000 Appendix IX Page 2 of 3 o (4) Description of device: The NT2000 is… | 1991 |
| † | K933176 | Neurotech 2000 (NT2000) | 1993 |
What descends from it? (80)
See all 802 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?
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?
The NT2000 is indicated for:
a) Transcutaneous Electrical Nerve Stimulation (TENS) for the symptomatic relief and
management of chronic (long term) intractable pain and as an adjunctive treatment
in the management of post surgical and post traumatic acute pain problems.
b) Electrical Neuromuscular Stimulation for the purposes of relaxation of muscle
spasm, prevention or retardation of disuse muscle atrophy, muscle re-education,
increase local blood circulation, maintain or increase range of motion, immediate
post-surgical stimulation of calf muscles to prevent venous thrombosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972244: NT2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972244
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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