510(k) · Cleared
ClearedBeactive Brace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natures Pillows, Inc. · PMV Orthosis, Limb, For Back Pain
Cleared on Feb 26, 2016 as substantially equivalent to K821582 (Jerome Medical, 1982) after a 269-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Feb 26, 2016
- Review
- 269 days
- Class
- Class I
- Product code
- PMV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821582 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK821582 Warm'n Form Sports SupportsJerome Medical · 1982
- This deviceK151476 Beactive BraceNatures Pillows, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821582 | Warm'n Form Sports Supports | Jerome Medical | 1982 | — |
| 0 (this device) | K151476 | Beactive Brace | Natures Pillows, Inc. | 2016 | — |
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 PMV? 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.
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 PMV devicesPMV Orthosis, Limb, For Back Pain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PMV
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PMV
Too few PMV 510(k)s in any year since 2007 to give a median.
Recalls per year · PMV
No recall names PMV since 2007.
Adverse event reports per year · PMV
1in 2024
MAUDE reports naming product code PMV, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Beactive Brace is applied to the to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the back of the knee for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151476: Beactive Brace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151476
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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