510(k) · Cleared
ClearedDSJ Massager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mego Afek AC, Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Dec 7, 2011 after a 100-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Dec 7, 2011
- Review
- 100 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK112479 DSJ MassagerMego Afek AC, Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK122112 2004-OC Massage System, 2008-OC Massage SystemBio Compression Systems, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK123829 Portable Therapeutix Squid Active Cold Compression Device and Cold…Portable Therapeutix, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK133483 Portable Therapeutix Squid Active Cold Compression Device and Cold…Portable Therapeutix · 2014
- Descendant · 3 generations on · 0 of its ownK230524 Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd · 2024
- Descendant · 2 generations on · 0 of its ownK213533 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL…Bio Compression Systems, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K1221122004-OC Massage System, 2008-OC Massage SystemBio Compression Systems, Inc. · 2013 · cites it directly2descendants
- K123829Portable Therapeutix Squid Active Cold Compression Device and Cold PackPortable Therapeutix, LLC · 2013 · cites it directly2descendants
- K133483Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for Otc UsePortable Therapeutix · 2014 · 2 generations on1descendant
- K230524Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd · 2024 · 3 generations on0descendants
- K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL…Bio Compression Systems, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112479 | DSJ Massager | Mego Afek AC, Ltd. | 2011 | — |
| +1 | K122112 | 2004-OC Massage System, 2008-OC Massage System | Bio Compression Systems, Inc. | 2013 | — |
| +1 | K123829 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack | Portable Therapeutix, LLC | 2013 | — |
| +2 | K133483 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for… | Portable Therapeutix | 2014 | — |
| +3 | K230524 | Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2024 | — |
| +2 | K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL… | Bio Compression Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 IRP? 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 IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 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? (7)
3 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, K122112 (Bio Compression Systems, Inc., 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, 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 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
What is it indicated for?
The DJS Massager is indicated for the temporary relief of minor muscle aches and pains, and for
temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112479: DSJ Massager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112479
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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