510(k) · Cleared
ClearedPulselife Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulse Life, Inc. · BWK Stimulator, Electro-Acupuncture
Cleared on Mar 27, 1984 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Mar 27, 1984
- Review
- 21 days
- Class
- Class U
- Product code
- BWK
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK840983 Pulselife StimulatorPulse Life, Inc. · 1984
- 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K840983 | Pulselife Stimulator | Pulse Life, Inc. | 1984 | — |
| +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 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081943 | Model ES-130 | 2008 | 7 |
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?
- Of its descendants, K081943 (Ito Co., Ltd., 2008) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K840983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K840983: Pulselife Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840983
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026