510(k) · Cleared
ClearedSmart-Tens, Model 456
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 Sep 12, 1996 as substantially equivalent to K912178 (Skylark Device Co., Ltd., 1991) after a 157-day review. Its family tree reaches back 1 generation to 1991. 7 later devices descend from it.
- Decided
- Sep 12, 1996
- Review
- 157 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912178 (1991). 7 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 deviceK961376 Smart-Tens, Model 456Bio-Medical Research, Ltd. · 1996
- Descendant · cites it directly · 5 of its ownK023913 Neurotech Baxolve Type 294Bio-Medical Research, Ltd. · 2003
- Descendant · 2 generations on · 4 of its ownK082190 Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models…Bio-Medical Research, Ltd. · 2009
- Descendant · 3 generations on · 2 of its ownK091317 Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK112934 Neurotech RecoveryBio-Medical Research, Ltd. · 2012
- Descendant · 4 generations on · 0 of its ownK102614 Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K023913Neurotech Baxolve Type 294Bio-Medical Research, Ltd. · 2003 · cites it directly5descendants
- K082190Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298Bio-Medical Research, Ltd. · 2009 · 2 generations on4descendants
- K091317Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009 · 3 generations on2descendants
- K112934Neurotech RecoveryBio-Medical Research, Ltd. · 2012 · 3 generations on0descendants
- K102614Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011 · 4 generations on0descendants
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) | K961376 | Smart-Tens, Model 456 | Bio-Medical Research, Ltd. | 1996 | — |
| +1 | K023913 | Neurotech Baxolve Type 294 | Bio-Medical Research, Ltd. | 2003 | — |
| +2 | K082190 | Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298 | Bio-Medical Research, Ltd. | 2009 | — |
| +3 | K091317 | Lumbofix Conductive Garment, Model 420 Back | Bio-Medical Research, Ltd. | 2009 | — |
| +3 | K112934 | Neurotech Recovery | Bio-Medical Research, Ltd. | 2012 | — |
| +4 | K102614 | Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 | Bio-Medical Research, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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…April, 1996 Smart-TENS, Model 456 TENS Transcutaneous Electrical Nerve Stimulator for pain relief; §882.5890 Bio Tens Model: ST-601 (Skylark Device Co. Ltd., 510(k) # K912178) Page 1 of 3 510(k) Notification for Smart-TENS: Appendix IX (4) (S) (6) Description of device: The Smart-T… | 1991 |
What descends from it? (7)
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?
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 Smart-TENS is used for transcutaneous electrical nerve stimulation
for the purposes of relief of chronic intractable 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/K961376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961376: Smart-Tens, Model 456.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961376
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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