Therm-X
The Therm-X single patient knee wrap is a flexible garment that circulates coolant to deliver cold, heat or alternating heat and cold therapy. It connects to the Therm-X treatment system…
The Therm-X single patient knee wrap is a flexible garment that circulates coolant to deliver cold, heat or alternating heat and cold therapy. It connects to the Therm-X treatment system and can provide thermal treatment with or without pneumatic compression.
The wrap belongs to a family of inflatable garments shaped for different body areas. The separate Therm-X console controls treatment time, temperature and compression settings, allowing the selected treatment cycle to be delivered through the garment.
Listed Item
Therm-X Butterfly Knee Small, SPU
Patient Use
Single patient garments are intended for one patient and can be disposed of when that patient’s treatment concludes. The knee wrap is a thermal treatment garment; the separate foot and calf garments used for deep vein thrombosis prophylaxis apply compression alone with the Therm-X Home system.
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 | Zenith Technical Innovations, LLC, United States |
|---|---|
| FDA product code | IRP |
| Device type | Massager, Powered Inflatable Tube |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5650 |
| Establishment | Manufacturer |
| 510(k) | K231912 |
| Record published | 2026-02-13 |
| Record revised | 2024-08-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 33 to 102 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity up to 60 % RH; Storage environment humidity up to 60 % RH; Handling environment temperature 33 to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Therm-X Hand SPU | In distribution | |
| Therm-X Butterfly Knee Small, SPU | In distribution | |
| Therm-X XL Shoulder Garment | In distribution | |
| Therm-X XL Shoulder Garment | In distribution | |
| Therm-X Butterfly Knee Large, SPU | In distribution | |
| Therm-X Butterfly Knee Large, SPU | In distribution | |
| Therm-X Butterfly Knee Small, SPU | In distribution | |
| Therm-X Shoulder SPU | In distribution | |
| Therm-X Shoulder SPU | In distribution | |
| Therm-X Hand SPU | 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 |
|---|---|
| K231912 | 2023-07-27 |
| K193550 | 2020-02-28 |
| K190854 | 2019-05-10 |
| K181149 | 2018-08-03 |
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.