510(k) · Cleared
ClearedLeg Massager (Models:RP-ALM070H, RP-ALM071H)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Ruiyi Business Technology Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Nov 20, 2024 as substantially equivalent to K193354 (Shenzhen Dongjilian Electronics Co., Ltd., 2020) and 1 other predicate after a 426-day review. Its family tree reaches back 9 generations to 1985. 2 later devices descend from it.
- Decided
- Nov 20, 2024
- Review
- 426 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K850316 (1985). 47 ancestors in all, the oldest K810338 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 5 generations between
- 3 generations backK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- 2 generations backK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- 1 generation backK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- This deviceK232965 Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK254200 Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003…Wenzhou Lingfeng Electronic Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251662 Air Compression Therapy Device (ST-504); Air Compression Therapy…Shenzhen Future Electronic Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 8 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 7 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 6 generations backK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- 5 generations backK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- 4 generations backK122154 Powerplay Muscle MassagerFig, LLC · 2012
- 3 generations backK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- 2 generations backK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- 1 generation backK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- This deviceK232965 Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See all- K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…Wenzhou Lingfeng Electronic Technology Co., Ltd. · 2026 · cites it directly0descendants
- K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…Shenzhen Future Electronic Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −8 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −7 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −6 | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −5 | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| −4 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| −3 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| −2 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| −1 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
| 0 (this device) | K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | 2024 | — |
| +1 | K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1… | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 2026 | — |
| +1 | K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device… | Shenzhen Future Electronic Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K193354 | Air Compression Therapy DeviceSummary page 6…ation Sponsor Shenzhen Dongjilian Electronics Co., Ltd. Trade/Device Name Air Compression Therapy Device 510(K) number K193354 Regulation Number 21 CFR 890.5650 Sponsor Medella Health Limited Trade/Device Name… | 2020 |
| * | K223729 | FLOWpresso Cleared while this submission was under review Summary page 6…egulation Number 21 CFR 890.5650 Sponsor Medella Health Limited Trade/Device Name FLOWpresso 510(K) number K223729 Regulation Number 21 CFR 890.5650 Page 2 of 14… | 2023 |
What descends from it? (2)
2 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?
- The line of descent spans 39 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 47 ancestors have a recall of any class.
- Of its descendants, K254200 (Wenzhou Lingfeng Electronic Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K193354.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232965: Leg Massager (Models:RP-ALM070H, RP-ALM071H).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232965
Report an extraction error
Are you the manufacturer?
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