510(k) · Cleared
ClearedDigi-Pro Tens, Model WL-2204 and WL-2205
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well-Life Healthcare, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Apr 30, 2002 after a 90-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- Apr 30, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK020314 Digi-Pro Tens, Model WL-2204 and WL-2205Well-Life Healthcare, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK032720 Gem-Stim Tens, Models GM3XY and GM3AXYGemore Technology Co, Ltd. · 2003
- Descendant · 2 generations on · 2 of its ownK042559 Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK030537 Digi-Pro Tens/WL-2203B,2204B,2204B-P1,2204B-P2,2205BWell-Life Healthcare, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK033857 T-Tech Digital, Model WL-22XXA SeriesWell-Life Healthcare, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK122948 Gem-Stim Combo StimulatorGemore Technology Co, Ltd. · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032720Gem-Stim Tens, Models GM3XY and GM3AXYGemore Technology Co, Ltd. · 2003 · cites it directly4descendants
- K042559Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004 · 2 generations on2descendants
- K030537Digi-Pro Tens/WL-2203B,2204B,2204B-P1,2204B-P2,2205BWell-Life Healthcare, Inc. · 2003 · cites it directly2descendants
- K033857T-Tech Digital, Model WL-22XXA SeriesWell-Life Healthcare, Inc. · 2003 · 2 generations on1descendant
- K122948Gem-Stim Combo StimulatorGemore Technology Co, Ltd. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020314 | Digi-Pro Tens, Model WL-2204 and WL-2205 | Well-Life Healthcare, Inc. | 2002 | — |
| +1 | K032720 | Gem-Stim Tens, Models GM3XY and GM3AXY | Gemore Technology Co, Ltd. | 2003 | — |
| +2 | K042559 | Gem-Twin Tens/ Models GM3XY/Z | Gemore Technology Co, Ltd. | 2004 | — |
| +1 | K030537 | Digi-Pro Tens/WL-2203B,2204B,2204B-P1,2204B-P2,2205B | Well-Life Healthcare, Inc. | 2003 | — |
| +2 | K033857 | T-Tech Digital, Model WL-22XXA Series | Well-Life Healthcare, Inc. | 2003 | — |
| +3 | K122948 | Gem-Stim Combo Stimulator | Gemore Technology Co, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (8)
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?
- Of its descendants, K032720 (Gemore Technology Co, Ltd., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020314: Digi-Pro Tens, Model WL-2204 and WL-2205.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020314
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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