510(k) · Cleared
ClearedRecoveryAir PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theragun, Inc. · IRP Massager, Powered Inflatable Tube
Cleared on Oct 4, 2021 as substantially equivalent to K140519 (Mego Afek AC, Ltd., 2014) after a 119-day review. Its family tree reaches back 1 generation to 2014. 4 later devices descend from it.
- Decided
- Oct 4, 2021
- Review
- 119 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K140519 (2014). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK140519 Recovery Pump 737RMego Afek AC, Ltd. · 2014
- This deviceK211745 RecoveryAir PROTheragun, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK241256 JetBoots PRO PlusTherabody, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242140 Air Compression Leg Massager (K-705)Jiale Health Technology Shenzhen Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243206 Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3…Sichuan Qianli-Beoka Medical Technology, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233238 Air Pressure Therapy System (Model:VU-IPC4M)Xiamen Weiyou Intelligent Technology Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K241256JetBoots PRO PlusTherabody, Inc. · 2024 · cites it directly1descendant
- K242140Air Compression Leg Massager (K-705)Jiale Health Technology Shenzhen Co., Ltd. · 2025 · 2 generations on0descendants
- K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4…Sichuan Qianli-Beoka Medical Technology, Inc. · 2025 · cites it directly0descendants
- K233238Air Pressure Therapy System (Model:VU-IPC4M)Xiamen Weiyou Intelligent Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K140519 | Recovery Pump 737R | Mego Afek AC, Ltd. | 2014 | — |
| 0 (this device) | K211745 | RecoveryAir PRO | Theragun, Inc. | 2021 | — |
| +1 | K241256 | JetBoots PRO Plus | Therabody, Inc. | 2024 | — |
| +2 | K242140 | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | 2025 | — |
| +1 | K243206 | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4… | Sichuan Qianli-Beoka Medical Technology, Inc. | 2025 | — |
| +1 | K233238 | Air Pressure Therapy System (Model:VU-IPC4M) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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 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? (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.
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K241256 (Therabody, Inc., 2024) has gone furthest, with 1 descendant 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. 2021, 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 RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO 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 RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211745: RecoveryAir PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211745
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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