Identity
- Trade Name
- Empower FDA UDI
- Generic Name
- Dynamic-response foot prosthesis FDA UDI
- Device Name
- 1A1-1 Empower, L, grey, brown FDA UDI
- Model / Reference
- 1A1-1=L29-7/1-15 FDA UDI
- Description
- 1A1-1 Empower, L, grey, brown FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04032767839650 FDA UDI
- FDA Product Code
- ISW FDA UDI
- GMDN Term
- Dynamic-response foot prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dynamic-response foot prosthesis
Empower by Otto Bock Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dynamic-response foot prosthesis.
- emPOWER — BIONX MEDICAL TECHNOLOGIES, INC. · Class II
- BiOM T2 — BIONX MEDICAL TECHNOLOGIES, INC. · Class II
- Walkasins — RXFUNCTION INC. · Class II
- Walkasins — RXFUNCTION INC. · Class II
- Empower — OTTO BOCK HEALTHCARE · Class II
- Empower — OTTO BOCK HEALTHCARE · Class II
- Empower — OTTO BOCK HEALTHCARE · Class II
- Empower — OTTO BOCK HEALTHCARE · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Otto Bock Healthcare
Sources (1)
- FDA UDI 5066084c-ad10-4f95-89bf-e80adcf8ccd0 33 fields · synced May 31, 2026