FDA UDI
In Commercial Distribution
🇺🇸 United States
Marodyne LiV
DI: 04260658910007
·
Model: 10107
·
BTT Health GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Marodyne LiV
- Primary DI
- 04260658910007
- Version / Model
- 10107
- Company Name
- BTT Health GmbH
- Labeler DUNS
- 341670851
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-01
- Public Version
- 1
- Public Version Date
- 2020-12-09
- Public Version Status
- New
- Public Device Record Key
- c58d2126-bd33-4229-94e5-7b65b4cc9e47
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61628 | Circulatory/musculoskeletal vibration therapy unit, platform | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260658910007 | GS1 |