510(k) · Cleared
ClearedArmory Motion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pain Management Technologies, Inc. · ILO Pack, Hot Or Cold, Water Circulating
Cleared on Jun 10, 2022 as substantially equivalent to K183702 (Breg, Inc., 2019) after a 259-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 10, 2022
- Review
- 259 days
- Class
- Class II
- Product code
- ILO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944567 (1995). 14 ancestors in all, the oldest K942796 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 4 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 3 generations backK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
- 2 generations backK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
- 1 generation backK183702 Polar Care WaveBreg, Inc. · 2019
- This deviceK213097 Armory MotionPain Management Technologies, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −4 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −3 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| −2 | K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017 | — |
| −1 | K183702 | Polar Care Wave | Breg, Inc. | 2019 | — |
| 0 (this device) | K213097 | Armory Motion | Pain Management Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 ILO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K183702 | Polar Care WaveSummary page 4…te Device: Trade/Device Name: Cold and Compression Therapy Model Number: Polar Care WaveTM Submitter: Breg, Inc. 510(k) Number: K183702 Product Code: IRP, ILO Type of Use: Prescription 6 === Page 5… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K183702.
How does its category compare?
All ILO devicesILO Pack, Hot Or Cold, Water Circulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ILO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · ILO
Too few ILO 510(k)s in any year since 2007 to give a median.
Recalls per year · ILO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILO
9in 2025
MAUDE reports naming product code ILO, 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 | 2 | — | 0 | 14 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 2 | 17 |
| 2010 | 0 | — | 0 | 171 |
| 2011 | 0 | — | 1 | 241 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 0 | — | 8 | 60 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 0 | — | 0 | 60 |
| 2016 | 0 | — | 0 | 44 |
| 2017 | 0 | — | 1 | 43 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 14 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213097: Armory Motion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213097
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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