Rheo Knee
KIT Powersupply Proprio/Rheo
1manufacturer
3catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
Record
| Listed by | Ossur Americas, United States |
|---|---|
| FDA product code | ISW |
| Device type | Assembly, Knee/Shank/Ankle/Foot, External |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-16 |
| Record revised | 2025-06-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 45 °C; Handling environment temperature -10 to 40 °C; Handling environment humidity 0 to 100 % RH; Storage environment humidity 10 to 90 % RH |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRX00421 | Withdrawn | |
| RKN13200 | Withdrawn | |
| RKN130203 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Empower | Otto Bock Healthcare GmbH | 621 |
| Symbionic Leg | Ossur Americas | 118 |
| Walkasins | Rxfunction Inc. | 18 |
| Power Knee | Ossur Americas | 11 |
| BiOM T2 | Bionx Medical Technologies, Inc. | 9 |
| emPOWER | Bionx Medical Technologies, Inc. | 7 |
| Bio Leg™ | Bionicm | 4 |
| BiOM T2 | Otto Bock Healthcare GmbH | 2 |
| C-Matt | Casco Manufacturing Solutions, Inc. | 1 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-08-29 | Class II | Device Design | Battery may dislodge from the Power Knee | 190 devices |
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.