# K981643: RTM DVT Prosoft Cuff Model Number PS100

- Pathway: 510(k) (Traditional)
- Applicant: R.T. Medical Services, Inc.
- Decided: Dec 14, 1998 after 220 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: 1 generation back to K881632 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988) Summary page 1.

## Indications for use
This product is intended for use with the Huntleigh DVT Flowtron pump to aid in the prevention of deep vein thrombosis in surgical, trauma and certain medical patients at risk for the formation of DVT. It is not intended for use on patients with known DVT or with any other intermittent compression device. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K981643
Methodology: https://510kreport.com/methodology