510(k) · Cleared
ClearedAculife, Model SMW-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inno-Health Technology, Inc. · BWK Stimulator, Electro-Acupuncture
Cleared on Mar 28, 2006 as substantially equivalent to K014273 (S.H.P. Intl. Pty., Ltd., 2002) after a 322-day review. Its family tree reaches back 2 generations to 1996. 9 later devices descend from it.
- Decided
- Mar 28, 2006
- Review
- 322 days
- Class
- Class U
- Product code
- BWK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954334 (1996). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954334 AcuplusS.H.P. Intl. Pty., Ltd. · 1996
- 1 generation backK014273 AcustimS.H.P. Intl. Pty., Ltd. · 2002
- This deviceK051197 Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK081943 Model ES-130Ito Co., Ltd. · 2008
- Descendant · 2 generations on · 3 of its ownK130768 Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK202861 Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)Wuxi Jiajian Medical Instrument Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK220153 Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081943Model ES-130Ito Co., Ltd. · 2008 · cites it directly7descendants
- K130768Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013 · 2 generations on3descendants
- K202861Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021 · 3 generations on2descendants
- K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)Wuxi Jiajian Medical Instrument Co., Ltd. · 2025 · 4 generations on0descendants
- K220153Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954334 | Acuplus | S.H.P. Intl. Pty., Ltd. | 1996 | — |
| −1 | K014273 | Acustim | S.H.P. Intl. Pty., Ltd. | 2002 | — |
| 0 (this device) | K051197 | Aculife, Model SMW-01 | Inno-Health Technology, Inc. | 2006 | — |
| +1 | K081943 | Model ES-130 | Ito Co., Ltd. | 2008 | — |
| +2 | K130768 | Jiajian CMN Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013 | — |
| +3 | K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021 | — |
| +4 | K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025 | — |
| +4 | K220153 | Needle Stimulator (Model: RJNS6-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K014273 | Acustim Our reading of the summary gave K014237, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ACUSTIM”. | 2002 |
What descends from it? (9)
2 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 10 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081943 (Ito Co., Ltd., 2008) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K014273.
How does its category compare?
All BWK devicesBWK Stimulator, Electro-Acupuncture: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051197: Aculife, Model SMW-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051197
Report an extraction error
Are you the manufacturer?
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