510(k) · Cleared
ClearedShape to Fit Compression Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tsung Hau Technology Co., Ltd. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Sep 17, 2010 as substantially equivalent to K062873 (E.C.I. USA Corporation, 2007) and 2 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Sep 17, 2010
- Review
- 71 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K955138 (1995). 6 ancestors in all, the oldest K830696 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
- 3 generations backK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
- 2 generations backK040353 Flight SockSsl Americas, Inc. · 2004
- 1 generation backK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
- This deviceK101906 Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK123085 Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM)…3M Company · 2012
Most influential descendants
Showing 1 of 1 · See all- K123085Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings…3M Company · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955138 | Anti-EM/GP Stockings | Jobst Institute, Inc. | 1995 | — |
| −3 | K032325 | Jobst Travel Socks | Bsn-Jobst, Inc. | 2003 | — |
| −2 | K040353 | Flight Sock | Ssl Americas, Inc. | 2004 | — |
| −1 | K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks | Knit-Rite, Inc. | 2009 | — |
| 0 (this device) | K101906 | Shape to Fit Compression Wear | Tsung Hau Technology Co., Ltd. | 2010 | — |
| +1 | K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel… | 3M Company | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 DWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062873 | Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and Ihealth…Summary page 1…Code ODWL. Shape to Fit Compression Socks (including same products offered for OEM applications) that belong to this category, and they are substantially equivalent to (K062873) Medical Support Stocking(Brand Name Supolar Netex Stockings), Therafirm anti-embolism stockings, Knit-Rite Inc ( K091141) and Jo… | 2007 |
| * | K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksSummary page 1…gory, and they are substantially equivalent to (K062873) Medical Support Stocking(Brand Name Supolar Netex Stockings), Therafirm anti-embolism stockings, Knit-Rite Inc ( K091141) and Jobst Institute Inc. (K032325). Shape to Fit Compression Socks and their substantial equivalents, mentioned above, are compr… | 2009 |
| * | K032325 | Jobst Travel SocksSummary page 1…uivalent to (K062873) Medical Support Stocking(Brand Name Supolar Netex Stockings), Therafirm anti-embolism stockings, Knit-Rite Inc ( K091141) and Jobst Institute Inc. (K032325). Shape to Fit Compression Socks and their substantial equivalents, mentioned above, are compression socks knitted by circular kn… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings… | 2012 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K123085 (3M Company, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWL devicesDWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DWL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DWL
111in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWL
No recall names DWL since 2007.
Adverse event reports per year · DWL
2in 2025
MAUDE reports naming product code DWL, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 3 | 214 | 0 | 7 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 5 | 43 | 0 | 10 |
| 2013 | 3 | 111 | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101906 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101906: Shape to Fit Compression Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101906
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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