Self-Adhesive Electrode 2" x 2" Pro Pulse HD

GUDID B243PSSA2X2PP4

Self-Adhesive Electrode

ELECTRO MEDICAL TECHNOLOGIES, LLC

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• Primary Device ID: B243PSSA2X2PP4
• NIH Device Record Key: 91559b92-b51c-4233-a355-e1d16e421478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self-Adhesive Electrode 2" x 2" Pro Pulse HD
• Version Model Number: 0
• Company DUNS: 160641309
• Company Name: ELECTRO MEDICAL TECHNOLOGIES, LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B243PSSA2X2PP4 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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• B243PSSA2X2PP4 - Self-Adhesive Electrode 2" x 2" Pro Pulse HD: 2018-07-06Self-Adhesive Electrode
• B243PSSA2X2PP4 - Self-Adhesive Electrode 2" x 2" Pro Pulse HD: 2018-07-06 Self-Adhesive Electrode