Compressible Limb Therapy System
Compressible Limb Therapy System MK300L combines a power unit with four-chamber leg garments. The controller applies pneumatic compression through the garment chambers for the selected…
Compressible Limb Therapy System MK300L combines a power unit with four-chamber leg garments. The controller applies pneumatic compression through the garment chambers for the selected therapy cycle.
The system has adjustable pressure, cycle-time and gradient settings. Variable timing determines the duration of the compression sequence.
Listed Item
Compressible Limb Therapy System pump with 2leg sleeves(Extra large), 1waist sleeve, 1arm sleeve and 4single hoses.
Controller and Garments
The power unit displays operating status and fault indications. The described MK300L configuration uses full-leg garments, with settings selected for the prescribed compression programme. Its intended applications include specified edema, venous-insufficiency and lymphedema therapy.
Who Else Makes It
Concentrated in Guangdong (17), Fujian (10), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shenzhen Yicai Health Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Zhangzhou Easepal Innovation Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 7 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Youwen Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Ryder Electronics (Xinfeng) Ltd. | Ganzhou | Jiangxi | Contract manufacturer | 1 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Fofo Medical Co., Ltd. | Xiamen | Fujian | Exporter | 18 |
| Shenzhen Ruiyi Business Technology Co., Ltd. | Shenzhen | Guangdong | Specification developer | 13 |
Showing 12 of 37. All 37 manufacturers in China registered for Massager, Powered Inflatable Tube
Record
| Listed by | Daesung Maref Co., Ltd., South Korea |
|---|---|
| FDA product code | IRP |
| Device type | Massager, Powered Inflatable Tube |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5650 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K112441 |
| Record published | 2016-10-24 |
| Record revised | 2024-09-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Box of 2, box, box of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MK300L | In distribution | |
| MK300L | In distribution | |
| LX7(V7) | In distribution | |
| Dsg0443L | In distribution | |
| Dsg0443XXL | In distribution | |
| LX7(V7) | In distribution | |
| LX7(V7) | In distribution | |
| Dsg0443XL | In distribution | |
| Lympha-Flow(LF400) | In distribution | |
| LX7(V7) | In distribution | |
| MK300L | In distribution | |
| LX7(V7) | In distribution | |
| MK300L | In distribution | |
| LX7(V7) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LF900 | Daesung Maref Co., Ltd. | 69 |
| LX9max | Daesung Maref Co., Ltd. | 47 |
| Game Ready | Avanos Medical, Inc. | 34 |
| Compressible Limb Therapy System(LX7(V7)) | Daesung Maref Co., Ltd. | 30 |
| VU | Xiamen Weiyou Intelligent Technology Co., Ltd. | 28 |
| NormaTec | Normatec Industries, LP | 27 |
| SP-2000 | Daesung Maref Co., Ltd. | 23 |
| BioTab | Vive Health LLC | 23 |
| Rapid Reboot | Rapid Reboot Recovery Products | 22 |
| 4 chamber sleeve | Daesung Maref Co., Ltd. | 21 |
| SP-1000 | Daesung Maref Co., Ltd. | 19 |
| Homedics | FKA Distributing Co., LLC | 18 |
Showing 12 of 230. All products under Massager, Powered Inflatable Tube
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231437 | 2023-07-19 |
| K202395 | 2021-09-01 |
| K203498 | 2021-07-02 |
| K203019 | 2021-06-22 |
| K160178 | 2017-01-11 |
| K150033 | 2015-04-20 |
| K112441 | 2012-01-17 |
| K102320 | 2011-03-04 |
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.