Identity
- Trade Name
- Walkasins FDA UDI
- Generic Name
- Dynamic-response foot prosthesis FDA UDI
- Device Name
- Leg Unit FDA UDI
- Model / Reference
- W-100 FDA UDI
- Description
- Leg Unit FDA UDI
Identifiers
- Catalog Number
- LU-20016 FDA UDI
- Primary DI / UDI-DI
- 00850004761021 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dynamic-response foot prosthesis
Walkasins by Rxfunction Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Empower — OTTO BOCK HEALTHCARE · Class II
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- 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 |
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Manufacturer
- Manufacturer
- Rxfunction Inc.
Sources (1)
- FDA UDI a4d21341-caa7-4fdb-bffc-0c10c470d71d 35 fields · synced Jun 8, 2026