ODFS Pace XL 00-001-0019

GUDID 05060195470441

Single channel, transcutaneous neuromuscular stimulator for relief of dropped foot. Also cleared for gait re-education and similar applications plus

ODSTOCK MEDICAL LIMITED

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 05060195470441
• NIH Device Record Key: 922ec1aa-5358-4c95-9862-49b8a895956e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODFS Pace XL
• Version Model Number: 1.1
• Catalog Number: 00-001-0019
• Company DUNS: 347303674
• Company Name: ODSTOCK MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441722439540
• Email: enquiries@odstockmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060195470441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171396

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2018-09-24
• Device Publish Date: 2018-08-22