Magnetolith
The FDA filing identifies MAGNETOLITH as a muscle stimulator that applies electromagnetic pulses without direct contact with the patient. It is indicated for muscle-spasm relaxation,…
The FDA filing identifies MAGNETOLITH as a muscle stimulator that applies electromagnetic pulses without direct contact with the patient.
It is indicated for muscle-spasm relaxation, prevention or retardation of disuse atrophy, muscle re-education and increasing local blood circulation.
Listed Item
Equipment for the extracorporeal magnetotransduction therapy.
System Components
The reusable, non-sterile system includes a control unit, handpiece applicator, applicator holder, mains cable and trolley. The applicator is cooled by circulating water. Its pulses are brief and do not increase tissue temperature.
Who Else Makes It
Concentrated in Guangdong (25), Beijing (3), Jiangsu (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Suzhou Fast ATM Electric Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Drtv Asia Ltd | Panyu Guangzhou | Guangdong | Specification developer | 16 |
Showing 12 of 33. All 33 manufacturers in China registered for Stimulator, Muscle, Powered
Record
| Listed by | Storz Medical AG, Switzerland |
|---|---|
| FDA product code | IPF |
| Device type | Stimulator, Muscle, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Establishment | Manufacturer |
| 510(k) | K203710 |
| Record published | 2021-06-01 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31500.0002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QB1 Nmes System | Motive Health, Inc. | 69 |
| MyndMove | Myndtec Inc | 44 |
| GEM-Stim | Gemore Technology Co., Ltd. | 38 |
| Chattanooga | DJO, LLC | 27 |
| ReGrasp | Rehabtronics, Inc. | 19 |
| Stimulation System | Edan Instruments, Inc. | 16 |
| e-vive II Nmes System | Motive Health, Inc. | 16 |
| L300 Go System | Bioness Medical, Inc. | 11 |
| Motive Knee System | Motive Health, Inc. | 9 |
| Ness H200® Wireless Hand Rehabilitation System | Bioness Medical, Inc. | 9 |
| BodyMed | Boxout, LLC | 8 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 7 |
Showing 12 of 204. All products under Stimulator, Muscle, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203710 | 2021-05-03 |
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.