VECTTOR Therapy System electrodes

GUDID 00869430000208

ALAN NEUROMEDICAL TECHNOLOGIES, L.L.C.

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: 00869430000208
• NIH Device Record Key: 49aefa8c-d928-4864-93cc-f1bde2cfa989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VECTTOR Therapy System electrodes
• Version Model Number: UF1250
• Company DUNS: 071665139
• Company Name: ALAN NEUROMEDICAL TECHNOLOGIES, L.L.C.
• 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: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.com
• Phone: (281) 259-8563
• Email: DrRhodes@VECTTOR.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	00869430000208 [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: 2016-08-19

Devices Manufactured by ALAN NEUROMEDICAL TECHNOLOGIES, L.L.C.

• 00869430000208 - VECTTOR Therapy System electrodes: 2018-07-06
• 00869430000208 - VECTTOR Therapy System electrodes: 2018-07-06
• 00869430000215 - VECTTOR Therapy System: 2018-07-06 VECTTOR Therapy System Interferential Therapy