# K232300: ElastiMed SACS

- Pathway: 510(k) (Traditional)
- Applicant: Elastimed, Ltd.
- Decided: Dec 22, 2023 after 143 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: 7 generations back to K944567 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162481: RF1400 Active Compression Wrap, Recovery Force, LLC (2017) Summary page 4.

## Most influential descendants
- K243177: Sacs Pro (2024), 0 descendants of its own

## Indications for use
The ElastiMed’s SACS device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings by stimulating blood flow in the legs. The SACS device is intended for: - 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, chronic lymphedema, and reduction of edema in the lower limbs. - As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. - Reduction of edema associated with soft tissue injuries, such as burns, postoperative or post-immobilization edema, or ligament sprains. The device can be used in the home or clinical setting.

Source page: https://510kreport.com/device/K232300
Methodology: https://510kreport.com/methodology