510(k) · Cleared
ClearedNormatec Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NormaTec Industries, LP · IRP Massager, Powered Inflatable Tube
Cleared on Mar 21, 2024 as substantially equivalent to K220217 (NormaTec Industries, LP, 2022) after a 65-day review. Its family tree reaches back 9 generations to 1985. 3 later devices descend from it.
- Decided
- Mar 21, 2024
- Review
- 65 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K850316 (1985). 20 ancestors in all, the oldest K810338 (1981). 3 later devices descend from it, 3 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 backK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018
- 1 generation backK220217 Normatec 3NormaTec Industries, LP · 2022
- This deviceK240122 Normatec EliteNormaTec Industries, LP · 2024
- Descendant · cites it directly · 0 of its ownK251905 Normatec Elite HipNormaTec Industries, LP · 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 ownK241446 Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)Sichuan Qianii-Beoka Medical Technoiogy Lnc. · 2024
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 backK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018
- 1 generation backK220217 Normatec 3NormaTec Industries, LP · 2022
- This deviceK240122 Normatec EliteNormaTec Industries, LP · 2024
Most influential descendants
Showing 3 of 3 · See all- K251905Normatec Elite HipNormaTec Industries, LP · 2025 · cites it directly0descendants
- 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
- K241446Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)Sichuan Qianii-Beoka Medical Technoiogy Lnc. · 2024 · 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 | K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018 | — |
| −1 | K220217 | Normatec 3 | NormaTec Industries, LP | 2022 | — |
| 0 (this device) | K240122 | Normatec Elite | NormaTec Industries, LP | 2024 | — |
| +1 | K251905 | Normatec Elite Hip | NormaTec Industries, LP | 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 | K241446 | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220217 | Normatec 3Summary page 5…nflatable tube massager Regulation Number: 21 CFR 890.5650 Product Code: IRP Regulation Medical Physical Medicine Speciality: Predicate Device: K220217 – Normatec 3 Reference Device: K221666 – Normatec Go Classification Name Powered inflatable tube massager Common/Usual… | 2022 |
| † | K221666 | Normatec Go | 2022 |
What descends from it? (3)
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?
- The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K251905 (NormaTec Industries, LP, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K220217.
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?
The Normatec Elite is an air pressure massager intended to temporarily relieve minor muscle aches
and/or pains, and to temporarily increase circulation to the treated areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240122: Normatec Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240122
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