# K251446: PlasmaFlow X Compression Sleeve Device (XPF0001)

- Pathway: 510(k) (Special)
- Applicant: Manamed, LLC
- Decided: Sep 17, 2025 after 131 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
PlasmaFlow X, Model XPF0001, is intended to be an easy-to-use portable system, prescribed by a physician, for use in the home or in a clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: * Aid in the prevention of DVT * Enhance blood circulation * Diminish post-operative pain and swelling * Reduce wound healing time * Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Source page: https://510kreport.com/device/K251446
Methodology: https://510kreport.com/methodology