510(k) · Cleared
ClearedMantra Tens Model NT3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mantra Intl. (Hk), Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Sep 3, 2004 as substantially equivalent to K020437 (Care Rehab, Inc., 2002) after an 88-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Sep 3, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895473 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK895473 DSX (TM), Digital SX, Quantum DSX, Model 4700SMedical Devices, Inc. · 1989
- 1 generation backK020437 Classic TensCare Rehab, Inc. · 2002
- This deviceK041520 Mantra Tens Model NT3Mantra Intl. (Hk), Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK091236 Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091236Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895473 | DSX (TM), Digital SX, Quantum DSX, Model 4700S | Medical Devices, Inc. | 1989 | — |
| −1 | K020437 | Classic Tens | Care Rehab, Inc. | 2002 | — |
| 0 (this device) | K041520 | Mantra Tens Model NT3 | Mantra Intl. (Hk), Ltd. | 2004 | — |
| +1 | K091236 | Mantra Combo, Model Mecs 320 | Mantra Intl. (Hk), Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K020437 | Classic TensSummary page 2…pulse width and rate. Substantial Equivalence: This product is substantially equivalent to the Classic TENS T M manufactured by Care Rehab, McLean, Virginia (K020437). Substantial equivalence is based upon: * The Mantra TENS Model NT3 has the same indications for use as the predicate… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091236 | Mantra Combo, Model Mecs 320 | 2009 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091236 (Mantra Intl. (Hk), Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020437.
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?
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041520: Mantra Tens Model NT3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041520
Report an extraction error
Are you the manufacturer?
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