Marodyne LiV
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…
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
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (6), Fujian (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Xiamen J-Brace Medical Equipment Co., Ltd. | Xiamen | Fujian | Repacker / relabeller | 24 |
| Hangzhou Zhongzhi Industry Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Zhejiang Mateside Medical Devices Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 21 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Fuzhou Feiwo Trading Co., Ltd. | Fuzhou | Fujian | Manufacturer | 11 |
Showing 12 of 27. All 27 manufacturers in China registered for Exerciser, Powered
Record
| Listed by | BTT Health Gmbh, Germany |
|---|---|
| FDA product code | BXB |
| Device type | Exerciser, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5380 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10107 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AlterG Anti-Gravity Treadmill | Lifeward CA, Inc. | 25 |
| Lokomat | Hocoma AG | 25 |
| APT Performer | Drive DeVilbiss Healthcare | 15 |
| Hand of Hope | Rehab-Robotics Company Limited | 14 |
| rebless | H Robotics Inc. | 10 |
| Medical HAL Lumbar Type | Cyberdyne Inc. | 9 |
| SwimEx Aquatherapy pool | SwimEx, Inc. | 8 |
| Chattanooga | DJO, LLC | 8 |
| RL-500 | Daesung Maref Co., Ltd. | 6 |
| THERA-Trainer toro | Medica Medizintechnik Gmbh | 6 |
| Handheld Direct Drive Cable Trainer | Beyond Power Inc. | 4 |
| MiraColt Generation 4 Seat | Chariot Innovations Inc | 4 |
Showing 12 of 91. All products under Exerciser, Powered
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-08-01 | Class II | Component design/selection | Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (st | 62 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.