510(k) · Cleared
ClearedRF1400 Active Compression Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Recovery Force, LLC · JOW Sleeve, Limb, Compressible
Cleared on Feb 16, 2017 as substantially equivalent to K140755 (Medical Compression Systems (Dbn), Ltd., 2014) after a 163-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 16, 2017
- Review
- 163 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944567 (1995). 13 ancestors in all, the oldest K915092 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 5 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 4 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 3 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 2 generations backK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
- 1 generation backK140755 Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014
- This deviceK162481 RF1400 Active Compression WrapRecovery Force, LLC · 2017
- Descendant · cites it directly · 1 of its ownK232300 ElastiMed SACSElastimed, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK243177 Sacs ProElastimed, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −5 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −4 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −3 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −2 | K110159 | Activecare SFT | Medical Compression Systems (Dbn), Ltd. | 2011 | — |
| −1 | K140755 | Activecare DVT, Activecare+SFT, and Activecare+DTX Systems | Medical Compression Systems (Dbn), Ltd. | 2014 | — |
| 0 (this device) | K162481 | RF1400 Active Compression Wrap | Recovery Force, LLC | 2017 | — |
| +1 | K232300 | ElastiMed SACS | Elastimed, Ltd. | 2023 | — |
| +2 | K243177 | Sacs Pro | Elastimed, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 JOW? 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 JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 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 |
|---|---|---|---|
| * | K140755 | Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsSummary page 6…dicate Devices The predicate devices of the RF1400 Active Compression Wrap are: • Primary predicate: ActiveCare DVT, manufactured by Medical Compression Systems (K140755) • Reference device: VascuTherm, manufactured by ThermoTek, Inc. (K061866) • Reference device: Vena Pro Vascular Therapy… | 2014 |
| † | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | 2006 |
| † | K133274 | Vena Pro | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232300 | ElastiMed SACS | 2023 | 1 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K232300 (Elastimed, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K140755.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, 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 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
What is it indicated for?
The RF1400 Active Compression Wrap is intended to be a portable and wearable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the lower limbs: o Aid in the prevention of DVT; o Enhance blood circulation; o Diminish post-operative pain and swelling; o Reduce wound healing time; o Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers…
Read the full statement (142 words)
The RF1400 Active Compression Wrap is intended to be a portable and wearable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the lower limbs:
o Aid in the prevention of DVT;
o Enhance blood circulation;
o Diminish post-operative pain and swelling;
o Reduce wound healing time;
o Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, chronic lymphedema, and reduction of edema in the lower limbs;
o As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
o Reduction of edema associated with soft tissue injuries, such as burns, postoperative or post-immobilization edema, or ligament sprains.
The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162481: RF1400 Active Compression Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162481
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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