Marodyne LiV

Primary DI
04260658910007
Brand
Marodyne LiV
Company
BTT Health GmbH
Model
10107
Device 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
Published
2020-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260658910007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260658910007042606589100074260658910007

GMDN Terms#

Term, Definition table
TermDefinition
Circulatory/musculoskeletal vibration therapy unit, platformA portable, electrically-powered device designed as a standing platform/plate for delivery of therapeutic low-magnitude vibrations throughout the body to improve musculoskeletal structure/function and enhance blood and lymphatic flow. It may be intended as a treatment for osteoporosis or to improve posture, coordination, and balance by using high-frequency, low-intensity mechanical vibrations according to the user’s body mass/dynamics. The device is intended to be used in clinical and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341670851
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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