510(k) · Cleared
ClearedBack in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theodore Barash · FQM Bandage, Elastic
Cleared on Apr 27, 2004 as substantially equivalent to K013244 (Med Gen, Inc., 2001) after a 106-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 27, 2004
- Review
- 106 days
- Class
- Class I
- Product code
- FQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013244 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK013244 Comfortcare Compression Support Witih Magnets and Aegis Microbe…Med Gen, Inc. · 2001
- This deviceK040054 Back in Action Compression & Support with Magnets for the Lower…Theodore Barash · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013244 | Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield… | Med Gen, Inc. | 2001 | — |
| 0 (this device) | K040054 | Back in Action Compression & Support with Magnets for the Lower Back, Knee and… | Theodore Barash | 2004 | — |
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 FQM? 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? (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 |
|---|---|---|---|
| * | K013244 | Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare…Summary page 3…Anti-Bacterial Agent and Magnet Common Names and Classifications. Elastic Bandage Product Code FQM Predicate 510(k) Number: K0 13244 Predicate Name: ComfortCare Compression and Support with Anti-Bacterial and Magnet I.Device Descriptiomi - (a) Elasticized fitm… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All FQM devicesFQM Bandage, Elastic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FQM
FDA has decided no FQM device since 2007.
Median 510(k) review, days · FQM
Too few FQM 510(k)s in any year since 2007 to give a median.
Recalls per year · FQM
6in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQM
6in 2025
MAUDE reports naming product code FQM, 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 | 3 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 1 | 8 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 6 | 10 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 73 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For relief of minor physical discomforts incurred by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.
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/K040054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040054: Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040054
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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