H-Wave EWL

GUDID 00869844000214

Electrode, Cutaneous

ELECTRONIC WAVEFORM LAB, 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: 00869844000214
• NIH Device Record Key: ad701866-792b-4cab-b731-f2b7aeef6e28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-Wave EWL
• Version Model Number: 30007
• Company DUNS: 065105561
• Company Name: ELECTRONIC WAVEFORM LAB, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com
• Phone: 714-843-0463
• Email: conact@h-wave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869844000214 [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: 2016-09-15

Devices Manufactured by ELECTRONIC WAVEFORM LAB, INC

• 00869844000207 - H-Wave: 2019-10-23 Powered Muscle Stimulator
• 00869844000221 - H-Wave: 2019-10-23 Powered Muscle Stimulator
• 00869844000214 - H-Wave EWL: 2018-07-06Electrode, Cutaneous
• 00869844000214 - H-Wave EWL: 2018-07-06 Electrode, Cutaneous