510(k) · Cleared
ClearedAcutron Mentor Model 961
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microcurrent Research, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Nov 25, 1998 as substantially equivalent to K880042 (Davis Assoc., 1988) and 2 other predicates after a 177-day review. Its family tree reaches back 1 generation to 1988. 79 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 177 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K880042 (1988). 3 ancestors in all. 79 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK880042 AcutronDavis Assoc. · 1988
- This deviceK981976 Acutron Mentor Model 961Microcurrent Research, Inc. · 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 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · 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 | K880042 | Acutron | Davis Assoc. | 1988 | — |
| 0 (this device) | K981976 | Acutron Mentor Model 961 | Microcurrent Research, Inc. | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K880042 | AcutronSummary page 1…scutaneous electric nerve stimulator) Legally marketed predicate devices: 1) Acutron Multiwave 911E: Manufactured by Microcurrent Research, Inc., Phoenix, AZ FDA 510K #K880042B 2) Theratouch 4.7: Manufactured by Rich-Mar, Inola, OK FDA 510K #K932868 3) Dynatron 550: Manufactured by Dynatronics, Salt La… | 1988 |
| * | K932868 | Theratouch 4.7Summary page 1…1) Acutron Multiwave 911E: Manufactured by Microcurrent Research, Inc., Phoenix, AZ FDA 510K #K880042B 2) Theratouch 4.7: Manufactured by Rich-Mar, Inola, OK FDA 510K #K932868 3) Dynatron 550: Manufactured by Dynatronics, Salt Lake City, UT FDA 510K #K941577 Description of device: The Acutron Mentor i… | 1994 |
| * | K941577 | Dynatron 550Summary page 1…FDA 510K #K880042B 2) Theratouch 4.7: Manufactured by Rich-Mar, Inola, OK FDA 510K #K932868 3) Dynatron 550: Manufactured by Dynatronics, Salt Lake City, UT FDA 510K #K941577 Description of device: The Acutron Mentor is an electromedical device of advanced design that is capable of delivering precisel… | 1995 |
What descends from it? (79)
See all 791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990787 | TRIO 300 | 1999 | 78 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K990787 (Ito Co., Ltd., 1999) has gone furthest, with 78 descendants 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.
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, post-traumatic and post-surgical pain.
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/K981976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981976: Acutron Mentor Model 961.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981976
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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