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Marodyne LiV

FDA UDI

Class I (US FDA UDI)

by BTT Health GmbH

Identity

Trade Name
Marodyne LiV FDA UDI
Generic Name
Circulatory/musculoskeletal vibration therapy unit, platform FDA UDI
Device Name
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 FDA UDI
Model / Reference
10107 FDA UDI
Description
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 FDA UDI

Identifiers

Primary DI / UDI-DI
04260658910007 FDA UDI
FDA Product Code
BXB FDA UDI
GMDN Term
Circulatory/musculoskeletal vibration therapy unit, platform FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulatory/musculoskeletal vibration therapy unit, platform

Marodyne LiV by BTT Health GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulatory/musculoskeletal vibration therapy unit, platform.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BTT Health GmbH

Sources (1)

  • FDA UDI c58d2126-bd33-4229-94e5-7b65b4cc9e47 33 fields · synced May 30, 2026