iReliev ET-5454

GUDID 20853635002451

iReliev PlayMakar Wireless Electrode Pads

EXCELHEALTH, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode 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: 20853635002451
• NIH Device Record Key: 55c2b347-2103-433f-8119-a0ea8a55fe31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iReliev
• Version Model Number: ET-5454
• Catalog Number: ET-5454
• Company DUNS: 079213529
• Company Name: EXCELHEALTH, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com
• Phone: 855-723-2582
• Email: wecare@ireliev.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853635002457 [Primary]
GS1	20853635002451 [Package]; Contains: 00853635002457; Package: Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082065

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: 2018-01-12

On-Brand Devices [iReliev]

• 20853635002741: iReliev iRenew Pain Relief and Recovery System
• 10853635002461: iReliev PlayMakar Reusable Electrode Pad
• 20853635002451: iReliev PlayMakar Wireless Electrode Pads
• 10853635002447: iReliev PlayMakar Expandable Wireless Pods
• 00853635002433: iReliev PlayMakar Therapeutic Wearable System
• 00853635002280: iReliev Super Pads, Single Pack, 2/Pack, 300 per Case 10853635002287
• 00853635002273: iReliev Super Pads Refill Kit, Box of 3 Packs of qty 2, 3.5" x 5", 40 Per Case
• 00853635002266: iReliev Conductive Back Wrap, 40 per Case
• 00853635002259: iReliev TENS + EMS Strength & Recovery System
• 00853635002112: iReliev Premium Electrode Pads, 4/Pack, 350 per Case
• 00853635002051: iReliev Pads & Leads Refill Kit, 40 per Case
• 00853635002037: iReliev TENS Pain Relief System, 40 per Case