# K952975: Ankle Calf Exerciser Phlebopump

- Pathway: 510(k) (Traditional)
- Applicant: Prevent Products, Inc.
- Decided: Sep 25, 1996 after 456 days
- Product code: BXB (Exerciser, Powered)
- Device class: 1
- Regulation: 21 CFR 890.5380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ankle Calf Exerciser from Prevent Products, Inc.: named in the summary without a submission number
- (no number) Toronto Lower Limb Model Mobilimb L2: named in the summary without a submission number
- (no number) PlexiPump from NuTech: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K952975
Methodology: https://510kreport.com/methodology
