510(k) · Cleared
ClearedNeotonus MS-101 Magnetic Muscle Stimulator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neotonus, Inc. · IPF Stimulator, Muscle, Powered
Cleared on May 21, 1998 after a 218-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- May 21, 1998
- Review
- 218 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK973929 Neotonus MS-101 Magnetic Muscle Stimulator SystemNeotonus, Inc. · 1998
- Descendant · cites it directly · 18 of its ownK160992 HPM-6000BTL Industries, Inc. · 2016
- Descendant · 2 generations on · 11 of its ownK190456 BTL 799-2LBTL Industries, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
- Descendant · 3 generations on · 4 of its ownK200382 BTL-703-2Btl · 2021
- Descendant · 2 generations on · 3 of its ownK203488 emFieldZimmer Medizinsysteme GmbH · 2021
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K160992HPM-6000BTL Industries, Inc. · 2016 · cites it directly18descendants
- K190456BTL 799-2LBTL Industries, Inc. · 2019 · 2 generations on11descendants
- K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021 · 2 generations on4descendants
- K200382BTL-703-2Btl · 2021 · 3 generations on4descendants
- K203488emFieldZimmer Medizinsysteme GmbH · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973929 | Neotonus MS-101 Magnetic Muscle Stimulator System | Neotonus, Inc. | 1998 | — |
| +1 | K160992 | HPM-6000 | BTL Industries, Inc. | 2016 | — |
| +2 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| +2 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
| +3 | K200382 | BTL-703-2 | Btl | 2021 | — |
| +2 | K203488 | emField | Zimmer Medizinsysteme GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | — | RICH-MAR Theratouch electrical muscle stimulator Named without a submission number |
What descends from it? (21)
See all 212 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, K160992 (BTL Industries, Inc., 2016) has gone furthest, with 18 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?
The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The Neotonus MS-101 is indicated {v1 use in sumulating neuromuscular tissucs for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blaod circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles 1o 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/K973929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973929: Neotonus MS-101 Magnetic Muscle Stimulator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973929
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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