FDA UDI
In Commercial Distribution
🇺🇸 United States
Empower
DI: 04064409003648
·
Model: 1A1-2=R29-7/4
·
OTTO BOCK HEALTHCARE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Empower
- Primary DI
- 04064409003648
- Version / Model
- 1A1-2=R29-7/4
- Company Name
- OTTO BOCK HEALTHCARE
- Labeler DUNS
- 932133408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-01
- Public Version
- 1
- Public Version Date
- 2021-03-09
- Public Version Status
- New
- Public Device Record Key
- fc42b468-688e-44f6-8d22-ddad163069d2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 64725 | Mechatronic external ankle-foot prosthesis | A battery-powered electromechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion motion control is based on hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing motion and temperature and instantly adjusting motion resistance within a single step. Also known as a microprocessor-controlled ankle-foot (MPF), it may have various designs and functional features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04064409003648 | GS1 |