Identity
- Trade Name
- Bio Leg™ FDA UDI
- Generic Name
- Mechatronic external knee prosthesis FDA UDI
- Device Name
- Robotic prosthetic leg - black - large - robotic knee joint only FDA UDI
- Model / Reference
- SN007 FDA UDI
- Description
- Robotic prosthetic leg - black - large - robotic knee joint only FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010894811 FDA UDI
- FDA Product Code
- ISW FDA UDI
- GMDN Term
- Mechatronic external knee 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mechatronic external knee prosthesis
Bio Leg™ by Bionicm Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bionicm Inc.
Sources (1)
- FDA UDI ddd56e6e-921b-4da1-a295-aa7034f98bc4 33 fields · synced May 30, 2026