Bio Leg™

GUDID 00860010894859

Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, instruction manual and other printed materials, for Trial

BIONICM INC.

Mechatronic external knee prosthesis

• Primary Device ID: 00860010894859
• NIH Device Record Key: 6c90c683-6b1a-442e-bbed-ee950d0609b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio Leg™
• Version Model Number: BLP001T
• Company DUNS: 717916018
• Company Name: BIONICM INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010894859 [Primary]

FDA Product Code

• ISW: Assembly, Knee/Shank/Ankle/Foot, External

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-29
• Device Publish Date: 2025-08-21

On-Brand Devices [Bio Leg™]

• 00860010894811: Robotic prosthetic leg - black - large - robotic knee joint only
• 00860010894804: Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, i
• 00860010894859: Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, i
• 00860010894842: Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, i