LF900
LF900 is an intermittent pneumatic compression system. Air is delivered to a sleeve with four chambers and pressure moves sequentially from chamber one to four. FDA classifies it as a…
LF900 is an intermittent pneumatic compression system. Air is delivered to a sleeve with four chambers and pressure moves sequentially from chamber one to four. FDA classifies it as a powered inflatable tube massager.
The filing states that medical professionals and patients at home under medical supervision may use LF900 for listed conditions, including primary lymphedema, edema after trauma or sports injuries, post-immobilization edema and venous insufficiencies.
Listed Item
Main device 1ea, LEG SLEEVE XXLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Distribution Tubing 1ea [One set box]
Configuration in This Filing
For the K231437 device, the filing says the maximum pressure changed from 180 mmHg to 140 mmHg and a sleeve type was added. Its specifications list leg and arm sleeves, four chambers and an operating pressure range of 10 to 140 mmHg.
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) | K231437 |
| Record published | 2024-05-20 |
| Record revised | 2024-09-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Box of 2 |
| Distribution end date | 2023-03-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LF90100-OSW | In distribution | |
| LF90100-AS-2 | In distribution | |
| LF90100 | In distribution | |
| LF90200-OMX-2 | In distribution | |
| LF90100-OLW | In distribution | |
| LF90200-OLW | In distribution | |
| LF90200-BL | In distribution | |
| LF90200-OMX | In distribution | |
| LF90200-0 | In distribution | |
| LF90200-BX-2 | In distribution | |
| LF90200-OM | In distribution | |
| LF90100-BL | In distribution | |
| LF90200 | In distribution | |
| LF90100-OMW | In distribution | |
| LF90200-BX | In distribution | |
| LF90100-BZ | In distribution | |
| LF90200-OS-2 | In distribution | |
| LF90100-OHM | In distribution | |
| LF90200-OSX-2 | In distribution | |
| LF90200-OS | In distribution | |
| LF90200-OLW-2 | In distribution | |
| LF90100-OSX | In distribution | |
| LF90100-OL | In distribution | |
| LF90200-OM-2 | In distribution | |
| LF90100-OS | In distribution | |
| LF90200-BL-2 | In distribution | |
| LF90100-OMX | In distribution | |
| LF90200-BZ-2 | In distribution | |
| LF90100-BX | In distribution | |
| LF90200-OL | In distribution | |
| LF90200-OL-2 | In distribution | |
| LF90100-OM | In distribution | |
| LF90200-2 | In distribution | |
| LF90100-OAL | In distribution | |
| LF90200-OMW-2 | In distribution | |
| LF90100-OAM | In distribution | |
| LF90200-BZ | In distribution | |
| LF90200-OSW-2 | In distribution | |
| LF90200-OSW | In distribution | |
| LF90200-OSX | In distribution | |
| LF90100-OHW | In distribution | |
| LF90200-OMW | In distribution | |
| LF90200-ROMX | Withdrawn | |
| LF90200-RL-2 | Withdrawn | |
| LF90200-WX | Withdrawn | |
| LF90200-ROM-2 | Withdrawn | |
| LF90200-ROSW | Withdrawn | |
| LF90200-WZ | Withdrawn | |
| LF90200-AL | Withdrawn | |
| LF90200-AZ | Withdrawn | |
| LF90200-ROL | Withdrawn | |
| LF90200-ROMW | Withdrawn | |
| LF90200-CB | Withdrawn | |
| LF90200-ROM | Withdrawn | |
| LF90200-AS | Withdrawn | |
| LF90200-DZ | Withdrawn | |
| LF90200-RX-2 | Withdrawn | |
| LF90200-RX | Withdrawn | |
| LF90200-DL | Withdrawn | |
| LF90200-ROLW | Withdrawn | |
| LF90200-RL | Withdrawn | |
| LF90200-ROSX | Withdrawn | |
| LF90200-WL | Withdrawn | |
| LF90200-ROL-2 | Withdrawn | |
| LF90200-RZ | Withdrawn | |
| LF90200-RZ-2 | Withdrawn | |
| LF90200-AX | Withdrawn | |
| LF90200-DX | Withdrawn | |
| LF90200-ROS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| CoreTech | Vive Health LLC | 17 |
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.