510(k) · Cleared
ClearedModification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device; Promax-Libra, Tens Device; Promax-Mic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rehabilicare, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 12, 2002 as substantially equivalent to K982410 (Rehabilicare, Inc., 1998) and 3 other predicates after a 27-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.
- Decided
- Aug 12, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K872657 (1987). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK872657 Ultrapac II SX Plus (TM)Medical Devices, Inc. · 1987
- This deviceK022405 Modification to Promax-XP, Tens and Microcurrent Device…Rehabilicare, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK081835 Acticare IC and TseBioinduction Limited · 2009
- Descendant · 2 generations on · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK252712 STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK213802 StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK061828 Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007
Most influential descendants
Showing 5 of 5 · See all- K081835Acticare IC and TseBioinduction Limited · 2009 · cites it directly3descendants
- K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · 2 generations on2descendants
- K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026 · 3 generations on0descendants
- K213802StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022 · 2 generations on0descendants
- K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872657 | Ultrapac II SX Plus (TM) | Medical Devices, Inc. | 1987 | — |
| 0 (this device) | K022405 | Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens… | Rehabilicare, Inc. | 2002 | — |
| +1 | K081835 | Acticare IC and Tse | Bioinduction Limited | 2009 | — |
| +2 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| +3 | K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026 | — |
| +2 | K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022 | — |
| +1 | K061828 | Lorenz Biotech Aptiva, Version 2.13 | Lorenz Biotech S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K982410 | SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens DeviceSummary page 2…max family Models XP-4400, TN-4410, TS 4430. LBR-4420 and MC-4440 are substantially equivalent to the TENS and Microcurrent devices distributed under K982410, K930865 and K935132, respectively.… | 1998 |
| * | K930865 | Staodyn Maxima IiiSummary page 1…K9824 IO October 7, 1998 S M P , and SX Max III TENS i Inc. StayodynInc. K930865 February 17, 1993 Ultrapac IISX… | 1993 |
| * | K872657 | Ultrapac II SX Plus (TM)Summary page 1…February 17, 1993 Ultrapac IISX TENS Rehabilicare IS872657 June 25, 1987 Inc. HMC- Home Micro- Rehabilicare… | 1987 |
| * | K935132 | Home Microcurrent HMCSummary page 1…Rehabilicare IS872657 June 25, 1987 Inc. HMC- Home Micro- Rehabilicare K935132 December 2 1, Microcurrent current Inc. 1993… | 1994 |
What descends from it? (5)
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 model 4400 series of TENS and Microcurrent devices are indicated for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022405: Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device; Promax-Libra, Tens Device; Promax-Mic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022405
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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