AB FLEX

GUDID 00697294664386

EMS Belt

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00697294664386
• NIH Device Record Key: 746a9e54-ba82-42c2-9b56-04ecfdbe8cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AB FLEX
• Version Model Number: MC0386
• Company DUNS: 529920175
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-307-9792
• Email: richbell20@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697294664386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183103

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2020-04-20
• Device Publish Date: 2020-04-10

On-Brand Devices [AB FLEX]

• 00697294664485: EMS Belt
• 00697294664386: EMS Belt
• 06972946645062: EMS Belt
• 06972946644652: EMS Belt
• 06972946644133: EMS Belt
• 06972946643877: EMS Belt
• 06972946642962: EMS Belt
• 06972946644850: EMS Belt
• 06972946643860: EMS Belt