510(k) · Cleared
ClearedHygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200
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 12, 2002 after a 242-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Apr 12, 2002
- Review
- 242 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK012651 Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100…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 · cites it directly · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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
- K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · cites it directly1descendant
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012651 | Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200 | 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 | — |
| +1 | K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | Hygia Health Services, Inc. | 2009 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | — | Huntleigh Foot Wrap Garment Named without a submission number |
What descends from it? (7)
3 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 Huntleigh Foot Wrap is designed to enhance
circulation of blood in the venules and arterioles. It is to be used by patient’s in both the
home and institutional settings as a non-invasive therapeutic method to 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
Decrease compartmental pressures
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/K012651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012651: Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012651
Report an extraction error
Are you the manufacturer?
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