# K964425: A-V Impulse System Model 6060

- Pathway: 510(k) (Traditional)
- Applicant: Powell,Goldstein,Frazer & Murphy
- Decided: Jul 28, 1997 after 265 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K052691: Suretek Medical Reprocessed Compression Sleeves (2006), 0 descendants of its own

## Indications for use
Lower Extremity Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, post-bypass graft edema, post-operative edema secondary to venous ligation or venous stripping and edema secondary to sprains, strains and sports related injuries of the lower extremity. Reduces chronic edema. Assists in treating patients at risk for deep vein thrombosis (DVT) and Pulmonary embolism (PE), including providing pre-, intra, and post-operative prophylaxis for DVT and PE. Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease. Assists healing of cutaneous ulcers. Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery. Treats venous stasis, venous insufficiency and varicose veins. Reduces lymphedema, including lymphedema secondary to trauma and/or surgery and reduces or controls chronic lymphedema including post-paralytic lymphedema due to stroke or spinal cord injury. Upper Extremity Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, and edema secondary to sprains, strains and other sports related injuries of the upper extremity. Reduces chronic edema. Reduces circulatory disorders secondary to diminished blood flow. Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery. Reduces lymphedema, including lymphedema secondary to trauma and/or surgery and reduces or controls chronic lymphedema, including post-paralytic lymphedema due to stroke or spinal cord injury.

Source page: https://510kreport.com/device/K964425
Methodology: https://510kreport.com/methodology