510(k) · Cleared
ClearedAXUS ES-5 Electro-Acupuncture Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lhasa Oms, Inc. · BWK Stimulator, Electro-Acupuncture
Cleared on Feb 3, 2021 as substantially equivalent to K081943 (Ito Co., Ltd., 2008) after a 330-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Feb 3, 2021
- Review
- 330 days
- Class
- Class U
- Product code
- BWK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954334 (1996). 5 ancestors in all, the oldest K840983 (1984). No later device cites it as a predicate yet.
- Root · 4 generations backK954334 AcuplusS.H.P. Intl. Pty., Ltd. · 1996
- 3 generations backK014273 AcustimS.H.P. Intl. Pty., Ltd. · 2002
- 2 generations backK051197 Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006
- 1 generation backK081943 Model ES-130Ito Co., Ltd. · 2008
- This deviceK200636 AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954334 | Acuplus | S.H.P. Intl. Pty., Ltd. | 1996 | — |
| −3 | K014273 | Acustim | S.H.P. Intl. Pty., Ltd. | 2002 | — |
| −2 | K051197 | Aculife, Model SMW-01 | Inno-Health Technology, Inc. | 2006 | — |
| −1 | K081943 | Model ES-130 | Ito Co., Ltd. | 2008 | — |
| 0 (this device) | K200636 | AXUS ES-5 Electro-Acupuncture Device | Lhasa Oms, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 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 BWK? 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 BWK device
- #1 K244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)score 10.6 · 6 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 |
|---|---|---|---|
| * | K081943 | Model ES-130Summary page 4…BWK Device Class: Unclassified Panel: Neurology Predicate Device: 510(k) Number: K081943 Trade Name: ES-130 Common Name(s): Electro-Acupuncture Stimulator… | 2008 |
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 25 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K081943.
How does its category compare?
All BWK devicesBWK Stimulator, Electro-Acupuncture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · BWK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWK
212in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWK
No recall names BWK since 2007.
Adverse event reports per year · BWK
1in 2024
MAUDE reports naming product code BWK, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 212 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AXUS ES-5 Electro Acupuncture Device is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200636: AXUS ES-5 Electro-Acupuncture Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200636
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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