LX9max
LX9max is a powered inflatable tube massager. The filing lists leg sleeves, an arm sleeve and a center-body sleeve as accessories for the device. The summary lists clinics, hospitals,…
LX9max is a powered inflatable tube massager. The filing lists leg sleeves, an arm sleeve and a center-body sleeve as accessories for the device.
The summary lists clinics, hospitals, athlete training and home environments as use settings. It identifies the device as an over-the-counter product.
Listed Item
Main Device 1ea, Leg Sleeve (L) 2ea, Leg Sleeve (XXL) 2ea, Leg Extension Zipper (L) 2ea, Leg Extension Zipper (XXL) 2ea, Double Tubing 1ea [One Set Box]
Device Format
The filing identifies LX9max as the trade name and lists sleeve accessories and use environments for this powered massager.
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) | K203498 |
| Record published | 2021-12-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Packaging | Box of 2 |
| Distribution end date | 2021-12-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LX9M200-AL | In distribution | |
| LX9M100-CB | In distribution | |
| LX9M100-LLZ | In distribution | |
| LX9M100-ALX | In distribution | |
| LX9M200-BZ-2 | In distribution | |
| X9M200-AX | In distribution | |
| LX9M200-AZ | In distribution | |
| LX9M100 | In distribution | |
| LX9M100-LL | In distribution | |
| LX9M200 | In distribution | |
| LX9M200-BX-2 | In distribution | |
| LX9M100-LLXE | In distribution | |
| LX9M100-CBE | In distribution | |
| LX9M200-BX | In distribution | |
| LX9M200-BZ | In distribution | |
| LX9M100-AL | In distribution | |
| LX9M100-LLZE | In distribution | |
| LX9M100-LZ | In distribution | |
| LX9M200-BL-2 | In distribution | |
| LX9M200-AS | In distribution | |
| LX9M100-LX | In distribution | |
| LX9M200-BL | In distribution | |
| LX9M100-LLX | In distribution | |
| X9M200-CB | In distribution | |
| LX9M200-RAZ | Withdrawn | |
| LX9M200-RZ | Withdrawn | |
| LX9M200-RDX | Withdrawn | |
| LX9M200-RAL | Withdrawn | |
| LX9M200-RWL | Withdrawn | |
| LX9M200-WL | Withdrawn | |
| LX9M200-RDL | Withdrawn | |
| LX9M200-RWZ | Withdrawn | |
| LX9M200-RC | Withdrawn | |
| LX9M200-RFL | Withdrawn | |
| LX9M200-WX | Withdrawn | |
| LX9M200-RFZ | Withdrawn | |
| LX9M200-RFX | Withdrawn | |
| LX9M200-RAX | Withdrawn | |
| LX9M200-WZ | Withdrawn | |
| LX9M200-RX | Withdrawn | |
| LX9M200-RWX | Withdrawn | |
| LX9M200-RDZ | Withdrawn | |
| LX9M200-RL | Withdrawn | |
| LX9M200-RAS | Withdrawn | |
| LX9M200-DZ | Withdrawn | |
| LX9M200-DX | Withdrawn | |
| LX9M200-DL | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LF900 | Daesung Maref Co., Ltd. | 69 |
| 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.