Marodyne LiV

GUDID 04260658910007

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

BTT Health GmbH

Circulatory/musculoskeletal vibration therapy unit, platform

• Primary Device ID: 04260658910007
• NIH Device Record Key: c58d2126-bd33-4229-94e5-7b65b4cc9e47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Marodyne LiV
• Version Model Number: 10107
• Company DUNS: 341670851
• Company Name: BTT Health GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260658910007 [Primary]

FDA Product Code

• BXB: Exerciser, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-09
• Device Publish Date: 2020-12-01