# K040065: Jsa's Reprocessed Compression Sleeve Devices

- Pathway: 510(k) (Traditional)
- Applicant: Jack Speer and Assoc., Inc.
- Decided: Mar 29, 2004 after 76 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
The Jack Speer and Associates, Inc. Huntleigh Reprocessed Compression Sleeve is recommended for use in patients for whom external compression therapy using the Huntleigh Flowtron® System is indicated for the prevention of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombus formation. Intraoperative compression therapy is frequently indicated, sometimes adjunctively with medical measures, during orthopedic, trauma, urologic and general surgery, particularly in patients over the age of 40.

Source page: https://510kreport.com/device/K040065
Methodology: https://510kreport.com/methodology