Rheo Knee
RHEO KNEE XC 5YWARR incl 40MSC
7manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Zhejiang Qiangnao Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 2 |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
| Dongguan Chuangguo Daily Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Ossur Americas, United States |
|---|---|
| FDA product code | ISY |
| Device type | Joint, Knee, External Limb Component |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-16 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Handling environment humidity 0 to 100 % RH; Storage environment temperature 0 to 45 °C; Handling environment temperature -10 to 40 °C |
| Distribution end date | 2023-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RKN13140 | In distribution | |
| RKN13100 | In distribution | |
| RKN12100 | In distribution | |
| RKNXC0002 | In distribution | |
| RKN13110 | In distribution | |
| RKN130003 | In distribution | |
| RKN13210 | In distribution | |
| RKN13130 | In distribution | |
| RKN130002 | In distribution | |
| RKNXC0005 | In distribution | |
| RKNXC0003 | In distribution | |
| RKNXC230 | In distribution | |
| RKN130005 | In distribution | |
| RKN13240 | In distribution | |
| RKNLPCWB1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Capital | College Park Industries | 19 |
| Tehlin | TEH LIN Prosthetic & Orthopaedic, Inc. | 19 |
| Icon | College Park Industries | 13 |
| Spark | Brownmed | 6 |
| Slide.fit | Streifeneder ortho.production gmbH | 6 |
| Trulife | Trulife, Inc. | 6 |
| Power Knee | Ossur Americas | 5 |
| Guardian | College Park Industries | 5 |
| Imak Compression | Brownmed | 5 |
| Donjoy Performance | DJO, LLC | 4 |
| Victor | College Park Industries | 3 |
| Aura Plus | College Park Industries | 2 |
Showing 12 of 24. All products under Joint, Knee, External Limb Component
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ossur Iceland ehf. | UDI-DI | 2024-03-25 | Class II | Software design | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | |
| Ossur Iceland ehf. | UDI-DI | 2024-03-25 | Class II | Software design | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | 143 units |
| Ossur Iceland ehf. | UDI-DI | 2024-03-25 | Class II | Software design | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | 107 units |
| Ossur Iceland ehf. | UDI-DI | 2024-03-25 | Class II | Software design | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | 1 unit |
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.