Physiotrode

GUDID 00867754000256

PHYSIO TECH INC.

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: 00867754000256
• NIH Device Record Key: da070d73-cb1b-4944-9aef-a72d81c54d57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Physiotrode
• Version Model Number: PTOVAL
• Company DUNS: 176611101
• Company Name: PHYSIO TECH INC.
• 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: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com
• Phone: 804-273-9721
• Email: customerservice@physiotech.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867754000256 [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: 2016-06-03

On-Brand Devices [Physiotrode]

• 00867754000263: PT3X5
• 00867754000256: PTOVAL
• 00867754000249: PT3R
• 00867754000232: PT2R
• 00867754000225: PT1.25R
• 00867754000218: PT2X4
• 00867754000201: PT2X2