510(k) · Cleared
ClearedForte, Models CPS 400 Stim, CPS 200 Stim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Nov 6, 1998 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 71 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
71 later devices descend from it, 2 citing it directly.
- This deviceK982828 Forte, Models CPS 400 Stim, CPS 200 StimChattanooga Group, Inc. · 1998
- Descendant · cites it directly · 56 of its ownK061650 Select Tens, Model 4600SEmpi · 2007
- Descendant · 2 generations on · 33 of its ownK113037 Pain-AidPdi Works, LLC · 2012
- Descendant · 3 generations on · 32 of its ownK131159 SmartreliefChattem, Inc. · 2013
- Descendant · 2 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
- Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K061650Select Tens, Model 4600SEmpi · 2007 · cites it directly56descendants
- K113037Pain-AidPdi Works, LLC · 2012 · 2 generations on33descendants
- K131159SmartreliefChattem, Inc. · 2013 · 3 generations on32descendants
- K093324Empi ContinuumEmpi · 2010 · 2 generations on26descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982828 | Forte, Models CPS 400 Stim, CPS 200 Stim | Chattanooga Group, Inc. | 1998 | — |
| +1 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| +2 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| +3 | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| +2 | K093324 | Empi Continuum | Empi | 2010 | — |
| +3 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (71)
See all 712 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, K061650 (Empi, 2007) has gone furthest, with 56 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?
For VMS, Russian, Monophasic Hi-Volt
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Microcurrent, Interferential and Premodulated
Symptomatic relief of chronic, intractable pain
Management of pain associated with post-traumatic or post-operative conditions
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982828: Forte, Models CPS 400 Stim, CPS 200 Stim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982828
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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