510(k) · Cleared
ClearedFenzian Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eumedic Limited · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jul 16, 2004 as substantially equivalent to K951951 (Empi, 1996) after a 32-day review. Its family tree reaches back 1 generation to 1996. 12 later devices descend from it.
- Decided
- Jul 16, 2004
- Review
- 32 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951951 (1996). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951951 Focus Model 795 UnitEmpi · 1996
- This deviceK041575 Fenzian Treatment SystemEumedic Limited · 2004
- Descendant · cites it directly · 10 of its ownK042912 INTERX5000Neuro Resource Group, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK062641 Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1Avazzia, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK133779 CP Relief WandMid-America Medical Innovations, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK092117 Scenar, Model 10Ritm Okb Zao · 2010
- Descendant · 2 generations on · 1 of its ownK070217 Interx 1000/Derma 200 Stimulator for Cosmetic UseNeuro Resource Group, Inc. · 2008
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K042912INTERX5000Neuro Resource Group, Inc. · 2005 · cites it directly10descendants
- K062641Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1Avazzia, Inc. · 2007 · 2 generations on2descendants
- K133779CP Relief WandMid-America Medical Innovations, LLC · 2014 · 2 generations on1descendant
- K092117Scenar, Model 10Ritm Okb Zao · 2010 · 2 generations on1descendant
- K070217Interx 1000/Derma 200 Stimulator for Cosmetic UseNeuro Resource Group, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951951 | Focus Model 795 Unit | Empi | 1996 | — |
| 0 (this device) | K041575 | Fenzian Treatment System | Eumedic Limited | 2004 | — |
| +1 | K042912 | INTERX5000 | Neuro Resource Group, Inc. | 2005 | 1 |
| +2 | K062641 | Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1 | Avazzia, Inc. | 2007 | 3 |
| +2 | K133779 | CP Relief Wand | Mid-America Medical Innovations, LLC | 2014 | — |
| +2 | K092117 | Scenar, Model 10 | Ritm Okb Zao | 2010 | — |
| +2 | K070217 | Interx 1000/Derma 200 Stimulator for Cosmetic Use | Neuro Resource Group, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 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? (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 |
|---|---|---|---|
| * | K951951 | Focus Model 795 UnitSummary page 2…Transcutaneous Electrical Nerve Stimulator Classification 882.5890 TENS SE Predicate: Empi Focus 795 K951951 882.5890 Device Description: The Fenzian Treatment System is an electrical device designed for use… | 1996 |
What descends from it? (12)
See all 122 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?
TENS applications:
* Symptomatic relief and management of chronic, intractable pain
* Adjunctive treatment for post-surgical and post-trauma acute pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041575: Fenzian Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041575
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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