CuPiLO
CuPiLO’s listed variant UM605 is part of the Air Compression Leg Massager family. The filing describes a portable, rechargeable system that simulates kneading and stroking with inflatable…
CuPiLO’s listed variant UM605 is part of the Air Compression Leg Massager family. The filing describes a portable, rechargeable system that simulates kneading and stroking with inflatable pressure cuffs.
For people in good health, the stated use is temporary relief of mild muscle pain and discomfort and a temporary increase in blood circulation to the treatment areas.
Pressure System
The massager uses pneumatically controlled leg wraps actuated by an electronic air-pump unit. The filing describes shared indications across the listed models, while compatible inflatable garments vary by model.
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 | Shenzhen Urion Technology Co., Ltd., China |
|---|---|
| FDA product code | IRP |
| Device type | Massager, Powered Inflatable Tube |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5650 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K250046 |
| Record published | 2025-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Carton of 18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UM605 | 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 |
|---|---|
| K250046 | 2025-04-25 |
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.