510(k) · Cleared
ClearedFist Assist Devices Model FA-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fist Assist Devices, LLC · IRP Massager, Powered Inflatable Tube
Cleared on Jun 17, 2021 as substantially equivalent to K183169 (NormaTec Industries, LP, 2018) and 2 other predicates after a 136-day review. Its family tree reaches back 8 generations to 1985.
- Decided
- Jun 17, 2021
- Review
- 136 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K850316 (1985). 20 ancestors in all, the oldest K810338 (1981). No later device cites it as a predicate yet.
- 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 backK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018
- This deviceK210281 Fist Assist Devices Model FA-1Fist Assist Devices, LLC · 2021
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 | K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018 | — |
| 0 (this device) | K210281 | Fist Assist Devices Model FA-1 | Fist Assist Devices, LLC | 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 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K183169 | Pulse 2.0, Pulse Pro 2.0Summary page 4…5650 CLASSIFICATION NAME: Powered Inflatable Tube Massager PRODUCT CODE IRP PREDICATE DEVICES: 1. NormaTec Pulse 2.0 and Pulse Pro 2.0 (K183169) 2. Fig LLC, PowerPlay PPRT-01 (K122154) 3. ManaMed Inc., PlasmaFlight… | 2018 |
| * | K122154 | Powerplay Muscle MassagerSummary page 4…RODUCT CODE IRP PREDICATE DEVICES: 1. NormaTec Pulse 2.0 and Pulse Pro 2.0 (K183169) 2. Fig LLC, PowerPlay PPRT-01 (K122154) 3. ManaMed Inc., PlasmaFlight (K200351) INDICATION FOR USE: The Fist Assist Model FA-1 is… | 2012 |
| * | K200351 | PlasmaFlightSummary page 4…ec Pulse 2.0 and Pulse Pro 2.0 (K183169) 2. Fig LLC, PowerPlay PPRT-01 (K122154) 3. ManaMed Inc., PlasmaFlight (K200351) INDICATION FOR USE: The Fist Assist Model FA-1 is an arm air pressure massager intended to temporarily relieve minor mu… | 2020 |
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 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 20 ancestors has a recall.
- 2 other devices also cite its predicate K183169.
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 Fist Assist Model FA-1 is an arm massager intended to temporarily relieve minor muscle aches and/or pains, and to
temporarily increase circulation to the treated areas.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210281: Fist Assist Devices Model FA-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210281
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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