510(k) · Cleared
ClearedChattanooga Revolution Wireless
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo, LLC · IPF Stimulator, Muscle, Powered
Cleared on Apr 14, 2016 as substantially equivalent to K132284 (Djo, LLC, 2014) after a 113-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 14, 2016
- Review
- 113 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945509 (1995). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945509 FX-2 NMS (2CHANNEL Table Model)Fx-2 · 1995
- 2 generations backK062354 Vectra Genisys VMS FREncore Medical L.P. · 2007
- 1 generation backK132284 Vectra Neo Clinical Therapy SystemDjo, LLC · 2014
- This deviceK153696 Chattanooga Revolution WirelessDjo, LLC · 2016
- Descendant · cites it directly · 1 of its ownK210674 Shoulder PacemakerNcs Lab Srl · 2021
- Descendant · 2 generations on · 0 of its ownK220994 Shoulder PacemakerTMNcs Lab Srl · 2022
- Descendant · cites it directly · 0 of its ownK202186 TrueRelief DeviceTruerelief · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945509 | FX-2 NMS (2CHANNEL Table Model) | Fx-2 | 1995 | — |
| −2 | K062354 | Vectra Genisys VMS FR | Encore Medical L.P. | 2007 | — |
| −1 | K132284 | Vectra Neo Clinical Therapy System | Djo, LLC | 2014 | — |
| 0 (this device) | K153696 | Chattanooga Revolution Wireless | Djo, LLC | 2016 | — |
| +1 | K210674 | Shoulder Pacemaker | Ncs Lab Srl | 2021 | — |
| +2 | K220994 | Shoulder PacemakerTM | Ncs Lab Srl | 2022 | — |
| +1 | K202186 | TrueRelief Device | Truerelief | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K132284 | Vectra Neo Clinical Therapy SystemSummary page 4…(21 CFR 5890) Product Code: IPF, GZJ Regulatory Class: Class II Predicate Device: Vectra Neo (K132284) Device Description: The Chattanooga® Revolution Wireless is a neuromuscular electrical stimulation (NMES) device, which stimul… | 2014 |
What descends from it? (3)
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210674 (Ncs Lab Srl, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K132284.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional. Indications for Use: As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles…
Read the full statement (131 words)
The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a
Healthcare Professional.
Indications for Use:
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain
As a pulsed mode device, indications are for the following conditions:
- Relaxation of muscle spasm
- Increasing local blood circulation
- Retardation or prevention of disuse atrophy
- Maintenance or increase of range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153696: Chattanooga Revolution Wireless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153696
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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