510(k) · Cleared
ClearedFocus Model 795 Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 17, 1996 after a 387-day review. The FDA summary names its predicate without a number. 81 later devices descend from it.
- Decided
- May 17, 1996
- Review
- 387 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
81 later devices descend from it, 6 citing it directly.
- This deviceK951951 Focus Model 795 UnitEmpi · 1996
- Descendant · cites it directly · 48 of its ownK021100 300 PV Complete Electrotherapy SystemEmpi · 2002
- Descendant · 2 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
- Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · 4 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · cites it directly · 20 of its ownK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K021100300 PV Complete Electrotherapy SystemEmpi · 2002 · cites it directly48descendants
- K093324Empi ContinuumEmpi · 2010 · 2 generations on26descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
- K153704StriveDjo, LLC · 2016 · 4 generations on24descendants
- K050991The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951951 | Focus Model 795 Unit | Empi | 1996 | — |
| +1 | K021100 | 300 PV Complete Electrotherapy System | Empi | 2002 | — |
| +2 | K093324 | Empi Continuum | Empi | 2010 | — |
| +3 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +4 | K153704 | Strive | Djo, LLC | 2016 | — |
| +1 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Empi Focus Model 727 Named without a submission number | |
| * | — | Empi Respond Select Named without a submission number |
What descends from it? (81)
See all 816 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?
- Of its descendants, K021100 (Empi, 2002) has gone furthest, with 48 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?
As a TENS device, the Focus is indicated for the following conditions: symptomatic relief and management of chronic, intractable pain adjunctive treatment for post-surgical and post-trauma acute pain As a NMS/NMES device, the Focus is indicated for the following conditions: relaxation of muscle spasm prevention or retardation of disuse atrophy increasing local blood circulation muscle re-education prevention of venous thrombosis of the calf muscles…
Read the full statement (110 words)
As a TENS device, the Focus is indicated for the following conditions:
symptomatic relief and management of chronic, intractable pain
adjunctive treatment for post-surgical and post-trauma acute pain
As a NMS/NMES device, the Focus is indicated for the following conditions:
relaxation of muscle spasm
prevention or retardation of disuse atrophy
increasing local blood circulation
muscle re-education
prevention of venous thrombosis of the calf muscles immediately after surgery
maintaining or increasing range of motion
As a FES device, the Focus is indicated for the following condition:
stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient’s gait
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/K951951 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951951: Focus Model 795 Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951951
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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