510(k) · Cleared
Recalled · 2011INTERX5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Resource Group, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 17, 2005 as substantially equivalent to K041575 (Eumedic Limited, 2004) and 2 other predicates after a 208-day review. Its family tree reaches back 2 generations to 1996. 10 later devices descend from it. It has been recalled once.
- Decided
- May 17, 2005
- Review
- 208 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951951 (1996). 3 ancestors in all, the oldest K870947 (1987). 10 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK951951 Focus Model 795 UnitEmpi · 1996
- 1 generation backK041575 Fenzian Treatment SystemEumedic Limited · 2004
- This deviceK042912 INTERX5000Neuro Resource Group, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK062641 Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1Avazzia, Inc. · 2007 · Recalled
- Descendant · cites it directly · 1 of its ownK133779 CP Relief WandMid-America Medical Innovations, LLC · 2014
- Descendant · cites it directly · 1 of its ownK092117 Scenar, Model 10Ritm Okb Zao · 2010
- Descendant · cites it directly · 1 of its ownK070217 Interx 1000/Derma 200 Stimulator for Cosmetic UseNeuro Resource Group, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK053626 INTERX500 Flexible Array ElectrodeNeuro Resource Group, Inc. · 2006
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K062641Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1Avazzia, Inc. · 2007 · cites it directly2descendants
- K133779CP Relief WandMid-America Medical Innovations, LLC · 2014 · cites it directly1descendant
- K092117Scenar, Model 10Ritm Okb Zao · 2010 · cites it directly1descendant
- K070217Interx 1000/Derma 200 Stimulator for Cosmetic UseNeuro Resource Group, Inc. · 2008 · cites it directly1descendant
- K053626INTERX500 Flexible Array ElectrodeNeuro Resource Group, Inc. · 2006 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951951 | Focus Model 795 Unit | Empi | 1996 | — |
| −1 | K041575 | Fenzian Treatment System | Eumedic Limited | 2004 | — |
| 0 (this device) | K042912 | INTERX5000 | Neuro Resource Group, Inc. | 2005 | — |
| +1 | K062641 | Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1 | Avazzia, Inc. | 2007 | 3 |
| +1 | K133779 | CP Relief Wand | Mid-America Medical Innovations, LLC | 2014 | — |
| +1 | K092117 | Scenar, Model 10 | Ritm Okb Zao | 2010 | — |
| +1 | K070217 | Interx 1000/Derma 200 Stimulator for Cosmetic Use | Neuro Resource Group, Inc. | 2008 | — |
| +1 | K053626 | INTERX500 Flexible Array Electrode | Neuro Resource Group, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K041575 | Fenzian Treatment SystemSummary page 7…lassification Regulation: 882.5950, 890.5850, Panel: Neurology, Physical Medicine Product Code: GZJ, IPF Trade Name(s): InterX5000 Predicate Device: K041575 - Fenzian Treatment System K951951 - EMPI Focus 795 K870947 - Dynatron 500 Electrical Muscle Stimulator Description… | 2004 |
| * | K951951 | Focus Model 795 UnitSummary page 7….5850, Panel: Neurology, Physical Medicine Product Code: GZJ, IPF Trade Name(s): InterX5000 Predicate Device: K041575 - Fenzian Treatment System K951951 - EMPI Focus 795 K870947 - Dynatron 500 Electrical Muscle Stimulator Description: InterX means "Interactive". Inter… | 1996 |
| * | K870947 | Dynatron 500Summary page 7…Physical Medicine Product Code: GZJ, IPF Trade Name(s): InterX5000 Predicate Device: K041575 - Fenzian Treatment System K951951 - EMPI Focus 795 K870947 - Dynatron 500 Electrical Muscle Stimulator Description: InterX means "Interactive". InterX technology is designed to w… | 1987 |
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062641 | Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1 | 2007 | 2 |
| K133779 | CP Relief Wand | 2014 | 1 |
| K092117 | Scenar, Model 10 | 2010 | 1 |
| K070217 | Interx 1000/Derma 200 Stimulator for Cosmetic Use | 2008 | 1 |
| K053626 | INTERX500 Flexible Array Electrode | 2006 | 1 |
| K131513 | Scenar (Scelap, Enisar, Ipens) Cutaneous Electrode Family | 2014 | 0 |
| K071878 | Delta Scanner, Delta Scanner Pro, DS Spine Pro, DS Sports Pro and DS Rehab | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2011 | Not classified | Z-2105-2011 | Material/Component Contamination | Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K062641 (Avazzia, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K041575.
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 InterX5000 is indicated for symptomatic relief and management of chronic,
intractable pain, and adjunctive treatment in the management of post-surgical and
post-traumatic 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/K042912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042912: INTERX5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042912
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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