emPOWER
emPOWER Ankle System, Black
1manufacturer
7catalogue 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 | Bionx Medical Technologies, Inc. |
|---|---|
| FDA product code | ISW |
| Device type | Assembly, Knee/Shank/Ankle/Foot, External |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3500 |
| Premarket notification | Exempt |
| Record published | 2016-10-27 |
| Record revised | 2023-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| em0G | In distribution | |
| em1G | In distribution | |
| em3 | In distribution | |
| em1B | In distribution | |
| em2 | In distribution | |
| em4 | In distribution | |
| em0B | 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 |
| Bio Leg™ | Bionicm | 4 |
| 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.