510(k) · Cleared
ClearedAir Compression Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongjilian Electronics Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Jun 8, 2020 as substantially equivalent to K182668 (Rapid Reboot Recovery Products, LLC, 2018) and 2 other predicates after a 187-day review. Its family tree reaches back 8 generations to 1985. 20 later devices descend from it.
- Decided
- Jun 8, 2020
- Review
- 187 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K850316 (1985). 19 ancestors in all, the oldest K810338 (1981). 20 later devices descend from it, 9 citing it directly.
- Root · 8 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 7 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 6 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 5 generations backK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- 4 generations backK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- 3 generations backK122154 Powerplay Muscle MassagerFig, LLC · 2012
- 2 generations backK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- 1 generation backK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- This deviceK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK213745 Air Compression Therapy Device, model: ST-502Shenzhen Future Electronic Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK232965 Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK222991 Air Compression Leg Massager (model: EMK-701)Xiamen Emoka Health Science & Technology Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK222669 Cryopush Cold Compression DeviceChengdu Cryo-Push Medical Technology Co.,Ltd · 2022
- Descendant · 2 generations on · 2 of its ownK221666 Normatec GoNormaTec Industries, LP · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K213745Air Compression Therapy Device, model: ST-502Shenzhen Future Electronic Co., Ltd. · 2022 · cites it directly3descendants
- K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd. · 2024 · cites it directly2descendants
- K222991Air Compression Leg Massager (model: EMK-701)Xiamen Emoka Health Science & Technology Co., Ltd. · 2023 · cites it directly2descendants
- K222669Cryopush Cold Compression DeviceChengdu Cryo-Push Medical Technology Co.,Ltd · 2022 · cites it directly2descendants
- K221666Normatec GoNormaTec Industries, LP · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −7 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −6 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −5 | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −4 | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| −3 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| −2 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| −1 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| 0 (this device) | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
| +1 | K213745 | Air Compression Therapy Device, model: ST-502 | Shenzhen Future Electronic Co., Ltd. | 2022 | — |
| +1 | K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | 2024 | — |
| +1 | K222991 | Air Compression Leg Massager (model: EMK-701) | Xiamen Emoka Health Science & Technology Co., Ltd. | 2023 | — |
| +1 | K222669 | Cryopush Cold Compression Device | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2022 | — |
| +2 | K221666 | Normatec Go | NormaTec Industries, LP | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 K240122 Normatec Elitescore 18.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K182668 | Rapid Reboot Compression Therapy SystemSummary page 5…pression Therapy Touch Air Massaging NormaTec Pulse Pro Device System System 510(K) Number K182668 K030437 K160608 4. Description of Device Air Compression Therapy Device consists of… | 2018 |
| * | K030437 | Relaxor Perfect Touch Air Massaging SystemSummary page 5…ch Air Massaging NormaTec Pulse Pro Device System System 510(K) Number K182668 K030437 K160608 4. Description of Device Air Compression Therapy Device consists of an air pump, air pressure… | 2003 |
| * | K160608 | NormaTec Pulse and NormaTec Pulse ProSummary page 5…Tec Pulse Pro Device System System 510(K) Number K182668 K030437 K160608 4. Description of Device Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves wo… | 2016 |
What descends from it? (20)
See all 209 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213745 | Air Compression Therapy Device, model: ST-502 | 2022 | 3 |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | 2024 | 2 |
| K222991 | Air Compression Leg Massager (model: EMK-701) | 2023 | 2 |
| K222669 | Cryopush Cold Compression Device | 2022 | 2 |
| K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | 2021 | 2 |
| K223464 | Leg and Foot Air Wave Pressure Therapy Device | 2023 | 0 |
| K222924 | Leg Massager RF-ALM070 | 2022 | 0 |
| K221862 | YY-A02-B Overlapped Compression Therapy | 2022 | 0 |
| K212713 | Air compression leg massager HY-1117A | 2022 | 0 |
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 35 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K213745 (Shenzhen Future Electronic Co., Ltd., 2022) has gone furthest, with 3 descendants of its own.
- 15 other devices also cite its predicate K182668.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Compression Therapy Device 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 Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193354: Air Compression Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193354
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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