510(k) · Cleared
ClearedActitouch Act-Adaptive Compression Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tactile Systems Technology, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Jun 18, 2013 as substantially equivalent to K882683 (Jobst Institute, Inc., 1988) after a 53-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Jun 18, 2013
- Review
- 53 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882683 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK882683 Jobst Extremity Pump (R) System 7500Jobst Institute, Inc. · 1988
- This deviceK131193 Actitouch Act-Adaptive Compression Therapy SystemTactile Systems Technology, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK200353 ManaFlowManamed, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK240011 Lymphedema CompressionJkh Health Co., 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 |
|---|---|---|---|---|---|
| −1 | K882683 | Jobst Extremity Pump (R) System 7500 | Jobst Institute, Inc. | 1988 | — |
| 0 (this device) | K131193 | Actitouch Act-Adaptive Compression Therapy System | Tactile Systems Technology, Inc. | 2013 | — |
| +1 | K200353 | ManaFlow | Manamed, Inc. | 2020 | — |
| +2 | K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K882683 | Jobst Extremity Pump (R) System 7500Summary page 1…imb Sleeve (21 CFR 870.5800) Predicate Device With Which Substantial Equivalence is Claimed: Device Name: Extremity Pump 7500 Company: Jobst Institute 510(k) Number: K882683 Classification: Compressible limb sleeve (21 CFR §870.5800) Device Description: The ACTitouch™ System applies compression to t… | 1988 |
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 |
|---|---|---|---|
| K200353 | ManaFlow | 2020 | 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?
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ACTitouch™ Adaptive Compression Therapy system provides graduated compression in both sustained and intermittent settings for use in:
Enhancing venous return
Reducing venous leg ulcer healing time
Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
Treatment of chronic venous insufficiency
Reducing edema due to venous stasis
Treatment of lymphedema
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/K131193 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131193: Actitouch Act-Adaptive Compression Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131193
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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