Lower Limb Orthotics Ankle Foot Orthosis (AFO)

GUDID 00860013109851

Boston Brace International, Inc.

Ankle/foot orthosis

• Primary Device ID: 00860013109851
• NIH Device Record Key: 7e3b603d-7a82-4ed4-9412-ba085b3c8bff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lower Limb Orthotics
• Version Model Number: Ankle Foot Orthosis (AFO)
• Catalog Number: Ankle Foot Orthosis (AFO)
• Company DUNS: 801816158
• Company Name: Boston Brace International, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00860013109851 [Primary]

FDA Product Code

• ITW: Joint, Ankle, External Brace

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: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [Lower Limb Orthotics]

• 00860013109899: Reciprocating Gait Orthosis (RGO)
• 00860013109882: Hip Knee Ankle Foot Orthosis (HKAFO)
• 00860013109875: Knee Ankle Foot Orthosis (KAFO)
• 00860013109868: Knee Orthosis (KO)
• 00860013109851: Ankle Foot Orthosis (AFO)
• 00860013109844: Supramalleolar Orthosis (SMO)
• 00860010708194: University of California Berkley Orthosis (UCB)