FDA UDI
In Commercial Distribution
🇺🇸 United States
emPOWER
DI: B155EM0B0
·
Model: em0B
·
BIONX MEDICAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- emPOWER
- Primary DI
- B155EM0B0
- Version / Model
- em0B
- Company Name
- BIONX MEDICAL TECHNOLOGIES, INC.
- Labeler DUNS
- 788290471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-27
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 71f1f28f-00c5-4845-b7d8-74f8d01a4eaf
Device Description
emPOWER Ankle System, Black
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | Physical Medicine | 890.3500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43569 | Dynamic-response foot prosthesis | An artificial substitute for a foot designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It is available in a variety of designs (e.g., it may resemble the form of a natural foot, or have a split-toe design) and its construction is intended to enable the store and release of energy during the walking cycle to provide a sense of push-off and a more normal gait range. A dynamic-response foot is typically intended for an active and responsive patient to help increase activity level (e.g., vary walking speed, change direction quickly, walk long distances). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B155EM0B0 | HIBCC |