# K243177: Sacs Pro

- Pathway: 510(k) (Traditional)
- Applicant: Elastimed, Ltd.
- Decided: Dec 23, 2024 after 84 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K850316 (1985). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221666: Normatec Go, NormaTec Industries, LP (2022) Summary page 5.
- K232300: ElastiMed SACS, Elastimed, Ltd. (2023) Summary page 5.

## Indications for use
The ElastiMed’s SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by doing so, aids in the stimulation of blood flow in the legs. The SACS PRO device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device can be used in Clinics, hospital, athlete training, and home environments.

Source page: https://510kreport.com/device/K243177
Methodology: https://510kreport.com/methodology