Calmare Therapeutics, Inc.

GUDID 00861432000316

2" x 4" (5cm x 10cm) Rectangle Snap Electrode

CALMARE THERAPEUTICS INCORPORATED

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00861432000316
• NIH Device Record Key: a813c45e-251e-4b97-a530-a15ab4dd9847
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calmare Therapeutics, Inc.
• Version Model Number: CTI2040
• Company DUNS: 049294093
• Company Name: CALMARE THERAPEUTICS INCORPORATED
• 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: true
• 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

Customer Support Contacts

• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com
• Phone: 203.368.6044
• Email: CTT@CalmareTherapeutics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861432000316 [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: 2016-07-29

On-Brand Devices [Calmare Therapeutics, Inc.]

• 00861432000330: 2" x 2" (5cm x 5cm) Square Electrode
• 00861432000323: 0.9" x 1.1" (2.2cm x 2.8cm) Snap Eyelet, White Fabric Top Electrode
• 00861432000316: 2" x 4" (5cm x 10cm) Rectangle Snap Electrode
• 00861432000309: 2" x 2" (5cm x 5cm) Square Snap Electrode