7E Wellness

GUDID 08908008085321

Cranial Electrotherapy Stimulation (CES)

JOHARI DIGITAL HEALTHCARE LIMITED

Transcutaneous electrical stimulation electrode

• Primary Device ID: 08908008085321
• NIH Device Record Key: f6753cc0-ed2d-49fd-89eb-c202bb14629d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7E Wellness
• Version Model Number: Myocalme RC
• Company DUNS: 675938472
• Company Name: JOHARI DIGITAL HEALTHCARE LIMITED
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com
• Phone: 888-412-3160
• Email: info@7ewellness.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908008085321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090052

FDA Product Code

• JXK: Stimulator, Cranial Electrotherapy
• QJQ: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-08
• Device Publish Date: 2019-04-30

On-Brand Devices [7E Wellness]

• 08908008085321: Cranial Electrotherapy Stimulation (CES)
• 08908008085277: Physiotherapy Equipment
• 08908008085093: TORC BODY
• 08908008085079: MYOLIFT ULTRA
• 08908008085062: MYOLIFT
• 08908008085208: MY-O-CALME