Accu-O-Matic ET-0100

GUDID 00628235150057

Advance Transcutaneous Electrical Nerve Stimulator

ETD Electro-Therapeutic Devices Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system 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