# K162481: RF1400 Active Compression Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Recovery Force, LLC
- Decided: Feb 16, 2017 after 163 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.
2 later devices descend 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)
- K140755: Activecare DVT, Activecare+SFT, and Activecare+DTX Systems, Medical Compression Systems (Dbn), Ltd. (2014) Summary page 6.

## Most influential descendants
- K232300: ElastiMed SACS (2023), 1 descendant of its own
- K243177: Sacs Pro (2024), 0 descendants of its own

## Indications for use
The RF1400 Active Compression Wrap is intended to be a portable and wearable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the lower limbs: o Aid in the prevention of DVT; o Enhance blood circulation; o Diminish post-operative pain and swelling; o Reduce wound healing time; o 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; o As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. o 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. The device is intended for use in an adult patient population.

Source page: https://510kreport.com/device/K162481
Methodology: https://510kreport.com/methodology