510(k) · Cleared
ClearedElectro-Acupuncture: Aculife/Model Idoc-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 Apr 2, 2010 as substantially equivalent to K051197 (Inno-Health Technology, Inc., 2006) after a 276-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 2, 2010
- Review
- 276 days
- Class
- Class U
- Product code
- BWK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954334 (1996). No later device cites it as a predicate yet.
- 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 deviceK091933 Electro-Acupuncture: Aculife/Model Idoc-01Inno-Health Technology, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K051197 | Aculife, Model SMW-01Summary page 1…tory Class: Unclassified. Product Code: BWK. Substantial equivalence: lnno-Health Aculife Electro-Acupuncture/ model SMW-01 (510OK number: K051197) Description of the Device: The device consists of a battery powered portable instrument, with a basic power pack which… | 2006 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- 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. 2010, 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 ACULIFE/Model IDOC-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 IDOC-01 is intended for the stimulation at hands of patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091933: Electro-Acupuncture: Aculife/Model Idoc-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091933
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