Eu Mdr Eu Md Class 2a On The Market

Mynd

MYND is a medical device designed to be used in the home healthcare environment for the treatment and prevention of frequent episodic and chronic migraine headaches. It is suitable for use by all who can control the device and understand the instructions. There is currently no evidence of effectiveness for users under the age of 18.

Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05033435134359
Basic UDI-DI Code
5033435K00122ZD
Reference
K-MYND
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Programme 1 is designed to treat migraine attacks and has a duration of 60 minutes. It should be applied when the migraine is already present or, preferably, when the first signs of the next migraine attack are felt. There is no daily limit for using relief mode, and sessions can be consecutive. It should be noted that side effects are based on one 60-minute treatment per day. These side effects are all reversible and should not be a concern. There's no evidence to suggest that extended use worsens side effects' frequency or severity. Note you may need to increase intensity for extended use as your body becomes accustomed to the treatment. Programme 2 is designed to prevent migraines and will last for 20 minutes. This programme should be used once a day. Regular use helps to reduce the frequency of migraine attacks.

Medical Purpose

MYND is a medical device designed to be used in the home healthcare environment for the treatment and prevention of frequent episodic and chronic migraine headaches. It is suitable for use by all who can control the device and understand the instructions. There is currently no evidence of effectiveness for users under the age of 18.

CND Nomenclature Codes

Code Description
Z120622 MUSCLE STIMULATORS

Related Devices

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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