510(k) · Cleared
ClearedElectronic Muscle Stimulator - Microstim J-1304D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nisha Communication Industries · IPF Stimulator, Muscle, Powered
Cleared on Jul 13, 1998 after a 189-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 189 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 1 citing it directly.
- This deviceK980040 Electronic Muscle Stimulator - Microstim J-1304DNisha Communication Industries · 1998
- Descendant · cites it directly · 3 of its ownK030998 Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Healthonics, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK060669 Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK062616 Wellnesspro 2010Intelsource Group, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK062325 RS-4I Muscle Stimulator FamilyRs Medical · 2007
Most influential descendants
Showing 4 of 4 · See all- K030998Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Healthonics, Inc. · 2003 · cites it directly3descendants
- K060669Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006 · 2 generations on2descendants
- K062616Wellnesspro 2010Intelsource Group, Inc. · 2007 · 3 generations on0descendants
- K062325RS-4I Muscle Stimulator FamilyRs Medical · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980040 | Electronic Muscle Stimulator - Microstim J-1304D | Nisha Communication Industries | 1998 | — |
| +1 | K030998 | Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300 | Healthonics, Inc. | 2003 | — |
| +2 | K060669 | Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 | Healthonics, Inc. | 2006 | — |
| +3 | K062616 | Wellnesspro 2010 | Intelsource Group, Inc. | 2007 | — |
| +3 | K062325 | RS-4I Muscle Stimulator Family | Rs Medical | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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 19.6 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K980028 | FDA’s K980028 is Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030998 | Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300 | 2003 | 3 |
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, K030998 (Healthonics, Inc., 2003) has gone furthest, with 3 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?
(1) Relaxation of Muscle Spasm.
(2) Prevention or retardation of disuse atrophy.
(3) Increasing local bloog Circulation.
(4) Muscle re-education.
(5) Immediate Postsurgical stimulation of calg muscles to prevent venous thrombosis,
(6)-Maintaining ¢r 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/K980040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980040: Electronic Muscle Stimulator - Microstim J-1304D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980040
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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