# K964354: Artocool-S Water Circulating Cold Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ormed GmbH
- Decided: Aug 29, 1997 after 302 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 its predicate without a number.
- (no number) Theracool™ Water Circulating Cold Pack: named in the summary without a submission number
- (no number) Polar Care™ Water Circulating Cold Pack: named in the summary without a submission number
- (no number) Dr. Kool™ Water Circulating Cold Pack: named in the summary without a submission number
- (no number) Cryo Cuff™ Water Circulating Cold Pack: named in the summary without a submission number

## Indications for use
1. Treatment of pain and swelling of acute periarticular processes. 2. Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3. Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4. Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.

Source page: https://510kreport.com/device/K964354
Methodology: https://510kreport.com/methodology