7E Wellness

GUDID 08908008085208

JOHARI DIGITAL HEALTHCARE LIMITED

Transcutaneous electrical stimulation electrode

• Primary Device ID: 08908008085208
• NIH Device Record Key: cf3812b0-b85d-4347-b9b6-a0de91e1a6dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7E Wellness
• Version Model Number: MY-O-CALME
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908008085208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090052

FDA Product Code

• 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-04
• Device Publish Date: 2016-09-19

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