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Hello, this is my first post in the cove and consider myself quite a beginner in the med device industry.
I work for a very small startup company that is designing a electric plug in the wall percussive massage device. The device can be seen here:
biomechanicsystems.com/equipment.html
My question is: Does this device fall under the "active therapeutic device" as set out in the 93/42/EEC and fall under rule 9 as a class IIa device or can we classify the device as a simple active device and only have to apply to class I regulations under rule 12?
From my understanding the definitions can be found on page 52 and 55 of the directive and in the meddev on page 39 it describes some example devices which I think are a little more "intense" than our device. This is up to discretion and would love to someone with a little bit more experience to possibly pipe in.
THANK YOU SO MUCH
I am learning as I go and appreciate any replies!
I work for a very small startup company that is designing a electric plug in the wall percussive massage device. The device can be seen here:
biomechanicsystems.com/equipment.html
My question is: Does this device fall under the "active therapeutic device" as set out in the 93/42/EEC and fall under rule 9 as a class IIa device or can we classify the device as a simple active device and only have to apply to class I regulations under rule 12?
From my understanding the definitions can be found on page 52 and 55 of the directive and in the meddev on page 39 it describes some example devices which I think are a little more "intense" than our device. This is up to discretion and would love to someone with a little bit more experience to possibly pipe in.
THANK YOU SO MUCH
I am learning as I go and appreciate any replies!
