BTT Health GmbH

Address:Billerberg 7,Inning Bavaria,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Exerciser, Powered (BXB) (1)

Premarket Exempt

Yes

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Marodyne LiV - 04260658910007 Catalog Number :

Device Description : Marodyne LiV is a therapeutic medical device for bone growth stimulation. Specif Marodyne LiV is a therapeutic medical device for bone growth stimulation. Specific mechanical vibrations applied to the body respectively to the tissue have a positive impact to the bone stability and the entire musculoskeletal system. The Marodyne System emits vertical, low intensity vibrations to the human body. Based on this application, BTT Health GmbH specifies the below indications, where Marodyne LiV can successfully be applied:• Safe and effective treatment of osteoporosis• Maintain and increase bone mineral density (BMD)• Building muscle strength & muscle mass in the legs• Stimulate blood circulation & lymphatic flow• As a fall prevention device by improving balance,postural control and coordination

Device Class : 1

Duns Number: 341670851

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

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