510(k) · Cleared
ClearedPremier Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Imex · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 7, 2004 after a 194-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.
- Decided
- Jan 7, 2004
- Review
- 194 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK032003 Premier PlusAmerican Imex · 2004
- Descendant · cites it directly · 15 of its ownK061516 Staodyn Max Preset, Model 4470Compex Technologies, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- Descendant · 3 generations on · 7 of its ownK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK120398 Witouch ProHollywog, LLC · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K061516Staodyn Max Preset, Model 4470Compex Technologies, Inc. · 2007 · cites it directly15descendants
- K110350Kneehab XPBio-Medical Research, Ltd. · 2011 · 2 generations on9descendants
- K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 2015 · 3 generations on7descendants
- K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016 · 4 generations on4descendants
- K120398Witouch ProHollywog, LLC · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032003 | Premier Plus | American Imex | 2004 | — |
| +1 | K061516 | Staodyn Max Preset, Model 4470 | Compex Technologies, Inc. | 2007 | — |
| +2 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| +3 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| +4 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| +2 | K120398 | Witouch Pro | Hollywog, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061516 | Staodyn Max Preset, Model 4470 | 2007 | 15 |
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, K061516 (Compex Technologies, Inc., 2007) has gone furthest, with 15 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?
Transcutaneous Electrical Nerve Stimulation devices are used for the symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032003: Premier Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032003
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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