510(k) · Cleared
ClearedAnkle Calf Exerciser Phlebopump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prevent Products, Inc. · BXB Exerciser, Powered
Cleared on Sep 25, 1996 after a 456-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 25, 1996
- Review
- 456 days
- Class
- Class I
- Product code
- BXB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 BXB? 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 |
|---|---|---|---|
| * | — | Ankle Calf Exerciser from Prevent Products, Inc. Named without a submission number | |
| * | — | Toronto Lower Limb Model Mobilimb L2 Named without a submission number | |
| * | — | PlexiPump from NuTech Named without a submission number |
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.
How does its category compare?
All BXB devicesBXB Exerciser, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BXB
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · BXB
Too few BXB 510(k)s in any year since 2007 to give a median.
Recalls per year · BXB
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BXB
4in 2025
MAUDE reports naming product code BXB, 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 | 1 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 1 | 4 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACE/PP is intended to exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg. It also retains the exercise function for maintaining muscle tone and preventing stiffness in the ankle joints.
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/K952975 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952975: Ankle Calf Exerciser Phlebopump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952975
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026