# K200353: ManaFlow

- Pathway: 510(k) (Traditional)
- Applicant: Manamed, Inc.
- Decided: Aug 6, 2020 after 175 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
Longest line of descent: 6 generations back to K915638 (1992). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131193: Actitouch Act-Adaptive Compression Therapy System, Tactile Systems Technology, Inc. (2013) Summary page 4.
- K160318: PlasmaFlow, Manamed, Inc. (2016) Summary page 4.
- K183631: medi pneumatic compression system (pcs) – brio (Model 651), Medi USA, LP (2019) Summary page 4.
- K142640: Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator, Bio Compression Systems, Inc. (2014) Summary page 4.

## Most influential descendants
- K240011: Lymphedema Compression (2024), 0 descendants of its own

## Indications for use
The ManaFlow system, part numbers MFLOWS51 and MFLOWS2, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: * Treatment of lymphedema * Treatment of chronic venous insufficiency * Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers * Reducing venous leg ulcer healing time * Reducing edema due to venous stasis » Enhancing venous return The device is intended for home, and hospital use.

Source page: https://510kreport.com/device/K200353
Methodology: https://510kreport.com/methodology