REUSABLE HOT/COLD GEL PAD

Organization name

PHYTO PERFORMANCE ITALIA SRL

SRN

IT-MF-000008118

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW135

  EUDAMED did not publish a description for this code.
• CW307

  EUDAMED did not publish a description for this code.
• CW414

  EUDAMED did not publish a description for this code.
• CW397

  EUDAMED did not publish a description for this code.
• CW999

  Always use the slip cover between the skin and the gel pad, to avoid burns or frostbite. Use it on sound skin.

Primary placement in Italy; available across 6 countries total.

Trade name

REUSABLE HOT/COLD GEL PAD

UDI-DI code

08031255036720

Basic UDI-DI

80312550003JQ

Reference / catalog number

P200.16/BUST3

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

3

Additional product description

Reusable gel pad - non-toxic - soft & flexible - microwaveable. It substitutes the ice bag and the hot water bottle. COLD THERAPY: dislocations, sprains, swellings, torn muscles, headache, toothache, insect bites, and in all situations, that may require a cold therapy. HOT THERAPY: abdominal pains, articular pains and in all situations, that may require a hot therapy. HOW TO USE COLD: store gel pad in the fridge. When it is at room temperature, leave it in the freezer for at least 2 hours before use. HOT: It can be heated in two ways, in a pot with hot water for 10 minutes at a maximum temperature of 60°C. Or in the microwave oven at max 350W for max 3 minutes (it must be placed in a container with some water).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES