Bio Leg™
Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, instruction manual and other printed materials, for Loaner
1manufacturer
4catalogue numbers in this listing
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 | Bionicm, Japan |
|---|---|
| FDA product code | ISW |
| Device type | Assembly, Knee/Shank/Ankle/Foot, External |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3500 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BLP001T | In distribution | |
| BLP001 | In distribution | |
| BLP001L | In distribution | |
| SN007 | In distribution |
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 |
| Rheo Knee | Ossur Americas | 3 |
| BiOM T2 | Otto Bock Healthcare GmbH | 2 |
| C-Matt | Casco Manufacturing Solutions, Inc. | 1 |
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.