Accu-O-Matic ET-0100

GUDID 00628235150057

Advance Transcutaneous Electrical Nerve Stimulator

ETD Electro-Therapeutic Devices Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00628235150057
• NIH Device Record Key: ff9851c8-e059-4505-b03a-5c66c0f7e73a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-O-Matic
• Version Model Number: Sp series
• Catalog Number: ET-0100
• Company DUNS: 253501613
• Company Name: ETD Electro-Therapeutic Devices Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca
• Phone: 9054758344
• Email: info@etdinc.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628235150057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K841427

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-09-06