P200.13/SPALLA

Organization name

PHYTO PERFORMANCE ITALIA SRL

SRN

IT-MF-000008118

Manufacturer status

Active

4 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.
• CW308

  EUDAMED did not publish a description for this code.
• CW311

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 2 countries total.

Trade name

not provided

UDI-DI code

08031255034627

Basic UDI-DI

80312550003JQ

Reference / catalog number

P200.13/SPALLA

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

CRYOFLEX SHOULDER is a new format of CRYOFLEX - reusable gel pad, always soft and flexible, for hot and cold therapy. Instructions for use: COLD 1. Cool CRYOFLEX in the freezer, for at least 1 hour before use, if it is at room temperature. 2. Place CRYOFLEX on shoulders or back area. Put a cloth between the pad and the area concerned, in order to avoid frostbite. 3. The gel pad temperature must be comfortable. Fix the velcro to secure it. HOT 1. Place CRYOFLEX in the microwave, power 800W/1 minute - 1500W/35 seconds, if it is at room temperature. 2. Place CRYOFLEX on shoulders or back area. Put a cloth between the pad and area concerned, in order to avoid burns. 3. The gel pad temperature must be comfortable. Fix the velcro to secure it.

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