# K203052: Movement and Compressions System (the MAC System)

- Pathway: 510(k) (Traditional)
- Applicant: Recovery Force, LLC
- Decided: Mar 21, 2021 after 165 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 K944567 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140755: Activecare DVT, Activecare+SFT, and Activecare+DTX Systems, Medical Compression Systems (Dbn), Ltd. (2014) Summary page 5.

## Indications for use
The Movement and Compressions System is intended to be a portable and wearable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the legs: * Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and, * As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium. The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.

Source page: https://510kreport.com/device/K203052
Methodology: https://510kreport.com/methodology