510(k) · Cleared
ClearedES-160
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lhasa Oms, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 24, 2006 as substantially equivalent to K904388 (Oms Medical Supplies, Inc., 1991) after a 308-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Feb 24, 2006
- Review
- 308 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904388 (1991). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK904388 Pointer F-3 TensOms Medical Supplies, Inc. · 1991
- This deviceK051020 ES-160Lhasa Oms, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK062003 Neuro Wave 6Lhasa Oms, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK081255 Scrambler ST 5 Tens DeviceCompetitive Technologies,Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK142666 Scrambler Therapy MC-5 A DeviceDelta International Services & Logistics S.R.L · 2015
- Descendant · 3 generations on · 0 of its ownK201458 Scrambler Therapy Technology (Model ST-5A)Delta International Services & Logistics S.R.L · 2020
- Descendant · cites it directly · 0 of its ownK080221 EA StimulatorHelio Medical Supplies, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K062003Neuro Wave 6Lhasa Oms, Inc. · 2007 · cites it directly3descendants
- K081255Scrambler ST 5 Tens DeviceCompetitive Technologies,Inc. · 2009 · cites it directly2descendants
- K142666Scrambler Therapy MC-5 A DeviceDelta International Services & Logistics S.R.L · 2015 · 2 generations on1descendant
- K201458Scrambler Therapy Technology (Model ST-5A)Delta International Services & Logistics S.R.L · 2020 · 3 generations on0descendants
- K080221EA StimulatorHelio Medical Supplies, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904388 | Pointer F-3 Tens | Oms Medical Supplies, Inc. | 1991 | — |
| 0 (this device) | K051020 | ES-160 | Lhasa Oms, Inc. | 2006 | — |
| +1 | K062003 | Neuro Wave 6 | Lhasa Oms, Inc. | 2007 | — |
| +1 | K081255 | Scrambler ST 5 Tens Device | Competitive Technologies,Inc. | 2009 | — |
| +2 | K142666 | Scrambler Therapy MC-5 A Device | Delta International Services & Logistics S.R.L | 2015 | — |
| +3 | K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | 2020 | — |
| +1 | K080221 | EA Stimulator | Helio Medical Supplies, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K904388 | Pointer F-3 TensSummary page 1…rical nerve stimulator, Class II, 21 CFR 882.5890. Legally marketed device for substantial equivalence comparison: Pointer F-3, K904388 Description of the device: The device consists of a battery powered portable instrument with a remote grounding pole and a hand… | 1991 |
| † | K946230 | Endura Reusable Tens and Nmes Electrodes | 1995 |
What descends from it? (5)
3 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, K062003 (Lhasa Oms, Inc., 2007) has gone furthest, with 3 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?
The ES-160 is designed to be used in the treatment of chronic, acute and post-operative pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051020 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051020: ES-160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051020
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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