Device Dossier
Endothermic cold therapy pack
Device Dossier for Endothermic cold therapy pack (Endothermic cold therapy pack, Class IIa, sponsor The Amazing Baby Company). ARTG record, intended…
- GMDN category: Endothermic cold therapy pack
Intended purpose
The Intended Purpose of the Instant Cold Pack is to treat common aches, pains, swelling and bruising associated with postpartum self-care. It is a self-contained unit comprised of a flexible, perforated pouch that holds water and an outer pouch that contains a chemical compound. The unit is activated by squeezing, which dissolves the chemical compound in the water creating an endothermic reaction. The pack is used with disposable underwear included in the kit.