510(k) · Cleared
ClearedModel ES-130
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ito Co., Ltd. · BWK Stimulator, Electro-Acupuncture
Cleared on Nov 24, 2008 as substantially equivalent to K051197 (Inno-Health Technology, Inc., 2006) and 1 other predicate after a 139-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.
- Decided
- Nov 24, 2008
- Review
- 139 days
- Class
- Class U
- Product code
- BWK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954334 (1996). 4 ancestors in all, the oldest K840983 (1984). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK954334 AcuplusS.H.P. Intl. Pty., Ltd. · 1996
- 2 generations backK014273 AcustimS.H.P. Intl. Pty., Ltd. · 2002
- 1 generation backK051197 Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006
- This deviceK081943 Model ES-130Ito Co., Ltd. · 2008
- Descendant · cites it directly · 3 of its ownK130768 Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK202861 Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)Wuxi Jiajian Medical Instrument Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK220153 Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK200636 AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130768Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013 · cites it directly3descendants
- K202861Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021 · 2 generations on2descendants
- K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)Wuxi Jiajian Medical Instrument Co., Ltd. · 2025 · 3 generations on0descendants
- K220153Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd. · 2022 · 3 generations on0descendants
- K200636AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954334 | Acuplus | S.H.P. Intl. Pty., Ltd. | 1996 | — |
| −2 | K014273 | Acustim | S.H.P. Intl. Pty., Ltd. | 2002 | — |
| −1 | K051197 | Aculife, Model SMW-01 | Inno-Health Technology, Inc. | 2006 | — |
| 0 (this device) | K081943 | Model ES-130 | Ito Co., Ltd. | 2008 | — |
| +1 | K130768 | Jiajian CMN Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013 | — |
| +2 | K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021 | — |
| +3 | K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025 | — |
| +3 | K220153 | Needle Stimulator (Model: RJNS6-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K051197 | Aculife, Model SMW-01Summary page 1…30 Primary Product Code: BWK Common Name: Stimulator, Electro-Acupuncture Class: Unclassified Predicate Devices: K051 197: ACULIFE/Model SMW-01 (Inno-Health Technology, Inc.) K840983: Pulselife Model PL2 (Pulse Life)… | 2006 |
| * | K840983 | Pulselife StimulatorSummary page 1…cture Class: Unclassified Predicate Devices: K051 197: ACULIFE/Model SMW-01 (Inno-Health Technology, Inc.) K840983: Pulselife Model PL2 (Pulse Life) Pre-Amendment: Model WQ-1IOB (Danghua Electronic Instrument Factor… | 1984 |
| * | — | Model WQ-1IOB Named without a submission number |
What descends from it? (7)
4 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130768 (Wuxi Jiajian Medical Instrument Co., Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K051197.
How does its category compare?
All BWK devicesBWK Stimulator, Electro-Acupuncture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 intended use of the ES- 130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081943: Model ES-130.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081943
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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