PALS

GUDID 00856817005406

AXELGAARD MANUFACTURING CO., LTD.

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: 00856817005406
• NIH Device Record Key: a5270c3d-e95f-4851-867e-3fefc13f8b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALS
• Version Model Number: J10R00
• Company DUNS: 150959401
• Company Name: AXELGAARD MANUFACTURING CO., LTD.
• 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: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856817005406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132422

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: 2016-03-31

On-Brand Devices [PALS]

• 00856817005550: SC100
• 00856817005543: PR100
• 00856817005536: 896350
• 00856817005529: 896240
• 00856817005512: 896230
• 00856817005505: 895340
• 00856817005499: 895250
• 00856817005482: 895402
• 00856817005475: 895240
• 00856817005468: 895220
• 00856817005451: 891200
• 00856817005444: 891100
• 00856817005437: 879300
• 00856817005420: 879200
• 00856817005413: 879100
• 00856817005406: J10R00
• 00851913006265: COM200