Identity
- Trade Name
- Empower FDA UDI
- Generic Name
- Mechatronic external ankle-foot prosthesis FDA UDI
- Model / Reference
- 1A1-2=L29-6/15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04064409003051 FDA UDI
- FDA Product Code
- ISW FDA UDI
- GMDN Term
- Mechatronic external ankle-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: Mechatronic external ankle-foot prosthesis
Empower by Otto Bock Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Odyssey iQ — COLLEGE PARK INDUSTRIES, INC. · Class I
- Odyssey iQ — COLLEGE PARK INDUSTRIES, INC. · Class I
- Odyssey iQ — COLLEGE PARK INDUSTRIES, INC. · Class I
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- Odyssey iQ — COLLEGE PARK INDUSTRIES, INC. · Class I
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 |
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Manufacturer
- Manufacturer
- Otto Bock Healthcare
Sources (1)
- FDA UDI 44af1267-ff8b-41da-9647-7778563e5527 32 fields · synced May 31, 2026