# K953648: A-V Impulse System Model 6060

- Pathway: 510(k) (Traditional)
- Applicant: Novamedix, Ltd.
- Decided: Feb 12, 1996 after 192 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.
60 later devices descend from it; 4 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040511: SCD Express Portable Compression System (2004), 38 descendants of its own
- K072666: Bioarterial Plus, Arterial Blood Flow Enhancement System (2007), 18 descendants of its own
- K131327: Bioarterial Plus Arterial Blood Flow Enhancement System (2013), 14 descendants of its own
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (2018), 12 descendants of its own
- K190854: Therm-X (2019), 11 descendants of its own

Source page: https://510kreport.com/device/K953648
Methodology: https://510kreport.com/methodology