510(k) · Cleared
ClearedScrambler Therapy Technology (Model ST-5A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delta International Services & Logistics S.R.L · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Dec 23, 2020 as substantially equivalent to K142666 (Delta International Services & Logistics S.R.L, 2015) after a 205-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Dec 23, 2020
- Review
- 205 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904388 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK904388 Pointer F-3 TensOms Medical Supplies, Inc. · 1991
- 4 generations backK051020 ES-160Lhasa Oms, Inc. · 2006
- 3 generations backK062003 Neuro Wave 6Lhasa Oms, Inc. · 2007
- 2 generations backK081255 Scrambler ST 5 Tens DeviceCompetitive Technologies,Inc. · 2009
- 1 generation backK142666 Scrambler Therapy MC-5 A DeviceDelta International Services & Logistics S.R.L · 2015
- This deviceK201458 Scrambler Therapy Technology (Model ST-5A)Delta International Services & Logistics S.R.L · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904388 | Pointer F-3 Tens | Oms Medical Supplies, Inc. | 1991 | — |
| −4 | K051020 | ES-160 | Lhasa Oms, Inc. | 2006 | — |
| −3 | K062003 | Neuro Wave 6 | Lhasa Oms, Inc. | 2007 | — |
| −2 | K081255 | Scrambler ST 5 Tens Device | Competitive Technologies,Inc. | 2009 | — |
| −1 | K142666 | Scrambler Therapy MC-5 A Device | Delta International Services & Logistics S.R.L | 2015 | — |
| 0 (this device) | K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | 2020 | — |
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 |
|---|---|---|---|
| * | K142666 | Scrambler Therapy MC-5 A DeviceSummary page 4…er Therapy® MC-5A Device (Manufactured in Korea by GEOMC Co., LTD under DIS&L license) Applicant: Delta International Services & Logistics S.r.l (DIS&L) 510(k) Number: # K142666 Device Identification: Scrambler Therapy® Technology Model ST-5A (Manufactured in Italy under DIS&L license) The associated acc… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
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. 2020, 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?
General Indications for Use :
• Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
• Symptomatic relief of acute pain.
• Symptomatic relief of post-operative pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201458 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201458: Scrambler Therapy Technology (Model ST-5A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201458
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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