Reflex

GUDID 00860013061104

Reflex is a rehabilitative exercise device that fits to the lower limb and is intended to facilitate knee stretching and strengthening exercises and perform measurement functions for rehabilitation related to musculoskeletal pathologies, injury, and/or surgery of the knee. Reflex is intended to be used in a clinical or home environment.

Assistive Technology Development, Inc.

Virtual-display rehabilitation system, non-supportive, home-use

• Primary Device ID: 00860013061104
• NIH Device Record Key: 045e54e5-3006-49d3-9db8-a72b95e53a2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reflex
• Version Model Number: KN33-LE
• Company DUNS: 119319634
• Company Name: Assistive Technology Development, 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013061104 [Primary]

FDA Product Code

• IKK: System, Isokinetic Testing And Evaluation

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: 2025-05-01
• Device Publish Date: 2025-04-23