510(k) · Cleared
ClearedAir Relax Pro Model AR-4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diode Art Engineering Doing Business AS Air Relax · IRP Massager, Powered Inflatable Tube
Cleared on Sep 2, 2021 as substantially equivalent to K211460 (Diode Art Engineering Doing Business AS Air Relax, 2021) after a 24-day review. Its family tree reaches back 11 generations to 1985.
- Decided
- Sep 2, 2021
- Review
- 24 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K850316 (1985). 22 ancestors in all, the oldest K810338 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 7 generations between
- 3 generations backK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- 2 generations backK191441 Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)Maxstar Industrial Co., Ltd. · 2021
- 1 generation backK211460 Air Relax Plus Model AR-3.0Diode Art Engineering Doing Business AS Air Relax · 2021
- This deviceK212491 Air Relax Pro Model AR-4.0Diode Art Engineering Doing Business AS Air Relax · 2021
Show all 11 generations
- Root · 11 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 10 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 9 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 8 generations backK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- 7 generations backK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- 6 generations backK122154 Powerplay Muscle MassagerFig, LLC · 2012
- 5 generations backK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- 4 generations backK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- 3 generations backK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- 2 generations backK191441 Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)Maxstar Industrial Co., Ltd. · 2021
- 1 generation backK211460 Air Relax Plus Model AR-3.0Diode Art Engineering Doing Business AS Air Relax · 2021
- This deviceK212491 Air Relax Pro Model AR-4.0Diode Art Engineering Doing Business AS Air Relax · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −10 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −9 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −8 | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −7 | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| −6 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| −5 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| −4 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| −3 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
| −2 | K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | Maxstar Industrial Co., Ltd. | 2021 | — |
| −1 | K211460 | Air Relax Plus Model AR-3.0 | Diode Art Engineering Doing Business AS Air Relax | 2021 | — |
| 0 (this device) | K212491 | Air Relax Pro Model AR-4.0 | Diode Art Engineering Doing Business AS Air Relax | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211460 | Air Relax Plus Model AR-3.0Summary page 4…Powered Inflatable Tube Massager Classification Name: IRP - Massager Powered Inflatable Tube (CFR 890.5650) Predicate Devices: K211460 – Air Relax Model AR-3.0 Device Description: This submission is for the Diode Art Engineering Air Relax Pro Model AR-4.0. The Ai… | 2021 |
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 36 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- None of the 22 ancestors has a recall.
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 Air Relax Pro Model AR-4.0 is intended 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 Air Relax Pro Model AR-4.0
simulates kneading and stroking of tissues by using an inflatable garment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212491: Air Relax Pro Model AR-4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212491
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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