510(k) · Cleared
ClearedSMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device
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 Nov 6, 1998 after a 116-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 116 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 4 citing it directly.
- This deviceK982410 SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens DeviceRehabilicare, Inc. · 1998
- Descendant · cites it directly · 14 of its ownK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
- Descendant · cites it directly · 13 of its ownK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
- Descendant · 2 generations on · 12 of its ownK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
- Descendant · 3 generations on · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
- Descendant · 3 generations on · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc. · 2001 · cites it directly14descendants
- K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002 · cites it directly13descendants
- K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006 · 2 generations on12descendants
- K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · 3 generations on11descendants
- K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982410 | SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device | Rehabilicare, Inc. | 1998 | — |
| +1 | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | Vertis Neuroscience, Inc. | 2001 | — |
| +1 | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG… | Vertis Neuroscience, Inc. | 2002 | — |
| +2 | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy System | Biowave Corporation | 2006 | — |
| +3 | K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | 2008 | — |
| +3 | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… | Spr Therapeutics, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | — | SMP, Model 48008, Transcutaneous Electrical Nerve Stimulator, Rehabilicare, Inc. Named without a submission number | |
| * | — | Ultrapac, Model 4500, Transcutaneous Electrical Nerve Stimulator, Rehabilicare Named without a submission number | |
| * | — | MAXIMA 111, Transcutaneous Electrical Nerve Stimulator, Stayodyn, Inc. Named without a submission number |
What descends from it? (25)
See all 254 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | 2001 | 14 |
| K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX | 2002 | 13 |
| K022405 | Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device… | 2002 | 5 |
| K020803 | Cefar Medical AB Cefar Primo | 2002 | 3 |
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?
- Of its descendants, K011702 (Vertis Neuroscience, Inc., 2001) has gone furthest, with 14 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?
TENS stimulation is used 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. [t has no curative value and should be
used only in conjunction with medical supervision.
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/K982410 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982410: SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982410
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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