510(k) · Cleared
ClearedRich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens & Therapeutic Ultrasound Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rich-Mar Corp. · LIH Interferential Current Therapy
Cleared on Aug 11, 1995 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Aug 11, 1995
- Review
- 100 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK952089 Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens &…Rich-Mar Corp. · 1995
- 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 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · 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) | K952089 | Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens & Therapeutic… | Rich-Mar Corp. | 1995 | — |
| +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 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 LIH? 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 LIH device
- #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
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? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160992 | HPM-6000 | 2016 | 18 |
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 LIH devicesLIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIH
Too few LIH 510(k)s in any year since 2007 to give a median.
Recalls per year · LIH
No recall names LIH since 2007.
Adverse event reports per year · LIH
1in 2025
MAUDE reports naming product code LIH, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952089: Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens & Therapeutic Ultrasound Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952089
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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