510(k) · Cleared
ClearedComfortcare Compression Support with Magnets Comfortcare Magnetic Insoles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med Gen, Inc. · FMQ Restraint, Protective
Cleared on Nov 20, 2001 after a 53-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 20, 2001
- Review
- 53 days
- Class
- Class I
- Product code
- FMQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK013239 Comfortcare Compression Support with Magnets Comfortcare Magnetic…Med Gen, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK040936 Petit Silma Elastic Bandage with Germanium/Titanium OxideLeda Co., Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040936Petit Silma Elastic Bandage with Germanium/Titanium OxideLeda Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013239 | Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles | Med Gen, Inc. | 2001 | — |
| +1 | K040936 | Petit Silma Elastic Bandage with Germanium/Titanium Oxide | Leda Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 FMQ? 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? (5)
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 |
|---|---|---|---|
| * | — | Becton-Dickinson compression support products Named without a submission number | |
| * | — | Ace compression support products Named without a submission number | |
| * | — | Futuro compression support products Named without a submission number | |
| * | — | Homedics products with magnets Named without a submission number | |
| * | — | Nikken products with magnets Named without a submission number |
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 |
|---|---|---|---|
| K040936 | Petit Silma Elastic Bandage with Germanium/Titanium Oxide | 2004 | 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?
- Of its descendants, K040936 (Leda Co., Ltd., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMQ devicesFMQ Restraint, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMQ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · FMQ
Too few FMQ 510(k)s in any year since 2007 to give a median.
Recalls per year · FMQ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FMQ
14in 2025
MAUDE reports naming product code FMQ, 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 | 0 | — | 0 | 16 |
| 2008 | 1 | — | 2 | 10 |
| 2009 | 1 | — | 22 | 42 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 1 | — | 0 | 31 |
| 2012 | 0 | — | 1 | 71 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 0 | — | 2 | 43 |
| 2015 | 0 | — | 0 | 33 |
| 2016 | 0 | — | 0 | 24 |
| 2017 | 0 | — | 0 | 54 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 1 | 57 |
| 2020 | 0 | — | 0 | 38 |
| 2021 | 0 | — | 1 | 33 |
| 2022 | 0 | — | 0 | 54 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actions associated with athlctic, workplace and at-home activities. Device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries. ComfortCare Absortek fabric construction provides for absorption and venting of…
Read the full statement (93 words)
ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actions associated with athlctic, workplace and at-home activities. Device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.
ComfortCare Absortek fabric construction provides for absorption and venting of perspiration from targeted areas, minimizing potential for skin irritation.
ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture from feet, minimizing damp environmeut conducive to breeding bacterial and fungal growth.
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/K013239 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013239: Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013239
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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