510(k) · Cleared
ClearedStaodyn Max Preset, Model 4470
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compex Technologies, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 6, 2007 as substantially equivalent to K032003 (American Imex, 2004) after a 250-day review. Its family tree reaches back 1 generation to 2004. 15 later devices descend from it.
- Decided
- Feb 6, 2007
- Review
- 250 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032003 (2004). 15 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK032003 Premier PlusAmerican Imex · 2004
- This deviceK061516 Staodyn Max Preset, Model 4470Compex Technologies, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK120398 Witouch ProHollywog, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK212832 TimeWaver FrequencyTimewaver Production GmbH · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K110350Kneehab XPBio-Medical Research, Ltd. · 2011 · cites it directly9descendants
- K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 2015 · 2 generations on7descendants
- K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016 · 3 generations on4descendants
- K120398Witouch ProHollywog, LLC · 2012 · cites it directly3descendants
- K212832TimeWaver FrequencyTimewaver Production GmbH · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032003 | Premier Plus | American Imex | 2004 | — |
| 0 (this device) | K061516 | Staodyn Max Preset, Model 4470 | Compex Technologies, Inc. | 2007 | — |
| +1 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| +2 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| +3 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| +1 | K120398 | Witouch Pro | Hollywog, LLC | 2012 | — |
| +3 | K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K032003 | Premier PlusSummary page 2…Max Preset 510(k) Submission VOL.00 New Brighton, MN 55112 Tel: 651-389-0771 Fax: 651-638-0477 Predicate Devices: American Imex Premier Plus -K032003 Intended Use: The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and m… | 2004 |
What descends from it? (15)
See all 153 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?
- Its one ancestor has no recall.
- Of its descendants, K110350 (Bio-Medical Research, Ltd., 2011) has gone furthest, with 9 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. 2007, this device’s year, is highlighted.
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 Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061516: Staodyn Max Preset, Model 4470.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061516
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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