# K040317: Ivc System

- Pathway: 510(k) (Traditional)
- Applicant: Mark H. Friedman
- Decided: May 7, 2004 after 88 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
To be used for cooling therapy when applied to the affected body surface during a migraine headache and for the reduction of pain from muscle spasms associated with migraine headaches.

Source page: https://510kreport.com/device/K040317
Methodology: https://510kreport.com/methodology