Physiologix Hot & Cold 3-IN-1 Brace

Organization name

Fleming Medical

SRN

IE-MF-000044303

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  Avoid excessive weight on brace(may cause gel pack to rupture and leak). Gel is non-toxic-discard if gel pack is punctured,tom or leaks.Watch brace carefully while heating.If brace begins to expand, turn off microwave. Use product only as directed. This product contains natural rubber latex and neoprene which may cause allergic reactions or skin irritations in some individuals. If rash develops or pain persists or increases, discontinues use and consult your doctor. Apply warm or cool therapy for no more than 20minutes and wait 2 hours before re-applying. Cold or Hot therpy not to be used by people unable to follow all usage instructions or remove the product, including children, infacts and some elderly. Consult your doctor or pharamacist before use if you have diabetes, poor circulation, heat disease, rheumatoldarthristis,or are prenant.

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Trade name

Physiologix Hot & Cold 3-IN-1 Brace

UDI-DI code

05099390410150

Basic UDI-DI

5099390HocopaRS

Reference / catalog number

MD481

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

Physiologix Hot & Cold 3-in-1 brace. Hot therapy: helps relieve stiffness,fatigue and relax tight muscles.Cold therapy:helps treat swelling, sprains,strains and bruising.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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