510(k) · Cleared
ClearedMantra Combo, Model Mecs 320
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 Jul 30, 2009 as substantially equivalent to K041520 (Mantra Intl. (Hk), Ltd., 2004) and 1 other predicate after a 94-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Jul 30, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K840346 (1984). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K840346 | Neuromusclar II | Mentor Corp. | 1984 | — |
| −2 | K971542 | Ortho DX Neuromuscular Stimulator | Rehabilicare, Inc. | 1997 | — |
| −1 | K021905 | Classic NMS | Care Rehab, Inc. | 2002 | — |
| 0 (this device) | K091236 | Mantra Combo, Model Mecs 320 | Mantra Intl. (Hk), Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K041520 | Mantra Tens Model NT3Summary page 2…ON 5.0 4. Substantial Equivalence This ploduct is substantially equivalent to the Mantra TENS Model NT3 (K041520) Combined with the Classic NMSTM manufactured Virginia (K021905). The device is physically by Care Rehab… | 2004 |
| * | K021905 | Classic NMSSummary page 2…ivalent to the Mantra TENS Model NT3 (K041520) Combined with the Classic NMSTM manufactured Virginia (K021905). The device is physically by Care Rehab-Inc of McLean NT3 and Classic NMSTM consisting of exactly identic… | 2002 |
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 25 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 7 ancestors has a recall.
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. 2009, 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?
a. TENS: The device is intended for the 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.
b. NMS: The device is recommended for use for the following conditions:
1. Relaxation of muscle spasms
2. Prevention of retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining and increasing range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091236 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091236: Mantra Combo, Model Mecs 320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091236
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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