510(k) · Cleared
ClearedNormaTec Pulse and NormaTec Pulse Pro
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 Apr 13, 2016 as substantially equivalent to K112890 (NormaTec Industries, LP, 2012) and 1 other predicate after a 41-day review. Its family tree reaches back 6 generations to 1985. 51 later devices descend from it.
- Decided
- Apr 13, 2016
- Review
- 41 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K850316 (1985). 17 ancestors in all, the oldest K810338 (1981). 51 later devices descend from it, 8 citing it directly.
- Root · 6 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 5 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 4 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 3 generations backK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- 2 generations backK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- 1 generation backK122154 Powerplay Muscle MassagerFig, LLC · 2012
- This deviceK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- Descendant · cites it directly · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- Descendant · cites it directly · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 10 of its ownK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018
- Descendant · 2 generations on · 7 of its ownK220217 Normatec 3NormaTec Industries, LP · 2022
- Descendant · cites it directly · 4 of its ownK201935 Air Pressure Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd. · 2021
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · cites it directly38descendants
- K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · cites it directly20descendants
- K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018 · cites it directly10descendants
- K220217Normatec 3NormaTec Industries, LP · 2022 · 2 generations on7descendants
- K201935Air Pressure Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd. · 2021 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −5 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −4 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −3 | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −2 | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| −1 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| 0 (this device) | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| +1 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| +1 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
| +1 | K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018 | — |
| +2 | K220217 | Normatec 3 | NormaTec Industries, LP | 2022 | — |
| +1 | K201935 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 12 | 0 |
| 2022 | 11 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K112890 | Normatec MVPSummary page 4…ble tube massager Class II Device Name: NormaTec Pulse and NormaTec Pulse Pro Predicate Devices: K112890 – NormaTec MVP K122154 - Figg, LLC PowerPlay model PPRT-01 Device Description: The NormaTec P… | 2012 |
| * | K122154 | Powerplay Muscle MassagerSummary page 4…s II Device Name: NormaTec Pulse and NormaTec Pulse Pro Predicate Devices: K112890 – NormaTec MVP K122154 - Figg, LLC PowerPlay model PPRT-01 Device Description: The NormaTec Pulse and Pulse Pro are powered inflatable tube massagers.… | 2012 |
What descends from it? (51)
See all 518 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182668 | Rapid Reboot Compression Therapy System | 2018 | 38 |
| K193354 | Air Compression Therapy Device | 2020 | 20 |
| K183169 | Pulse 2.0, Pulse Pro 2.0 | 2018 | 10 |
| K201935 | Air Pressure Therapy System | 2021 | 4 |
| K201982 | Air compression therapy system FO-3001; Air compression therapy system FO-3008 | 2021 | 3 |
| K191862 | Compression Therapy Device Model LGT-2200SP | 2019 | 1 |
| K212169 | Air compression therapy system FO3002 | 2021 | 0 |
| K210967 | Air Pressure Therapy System: VU-IPC06 | 2021 | 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 31 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K182668 (Rapid Reboot Recovery Products, LLC, 2018) has gone furthest, with 38 descendants 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. 2016, 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 Pulse and Pulse Pro 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/K160608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160608: NormaTec Pulse and NormaTec Pulse Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160608
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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