510(k) · Cleared
ClearedHygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygia Health Services, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Apr 11, 2002 after a 219-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Apr 11, 2002
- Review
- 219 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK012956 Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and…Hygia Health Services, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK031559 Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK051227 Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK203847 Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010
- Descendant · 3 generations on · 0 of its ownK093658 Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu…Renu Medical, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031559Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003 · cites it directly4descendants
- K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006 · 2 generations on2descendants
- K203847Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021 · 2 generations on0descendants
- K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
- K093658Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot…Renu Medical, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012956 | Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb | Hygia Health Services, Inc. | 2002 | — |
| +1 | K031559 | Renu Medical Reporcessed Compressible Limb Sleeves | Renu Medical, Inc. | 2003 | — |
| +2 | K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1 | Renu Medical, Inc. | 2006 | — |
| +2 | K203847 | Reprocessed Tri Pulse Compression Garment | Renu Medical, Inc. | 2021 | — |
| +1 | K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | Midwest Reprocessing Center, LLC | 2010 | — |
| +3 | K093658 | Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical… | Renu Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | NuTech® Combination Foot and Calf Wrap Named without a submission number |
What descends from it? (6)
2 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?
- Of its descendants, K031559 (Renu Medical, Inc., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Hygia Health Services Reprocessed NuTech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to:
e Prevent deep vein thrombosis
¢ Reduce wound healing time
¢ Treat and assist healing of venous leg ulcers
¢ Reduce edema caused by venous insufficiency in the lower extremities
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/K012956 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012956: Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012956
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026