EMS Belt

GUDID 06972946645703

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 06972946645703
• NIH Device Record Key: 3b48a80c-b8be-42b9-b1a6-0e05c4ace2fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMS Belt
• Version Model Number: MC0570
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972946645703 [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: 2021-05-25
• Device Publish Date: 2021-05-17

Devices Manufactured by

• 06972946645703 - EMS Belt: 2021-05-25
• 06972946645703 - EMS Belt: 2021-05-25
• 06972946643860 - AB FLEX: 2021-02-19 EMS Belt
• 06972946644850 - AB FLEX: 2021-02-19 EMS Belt
• 06972946642962 - AB FLEX: 2020-06-29 EMS Belt
• 06972946643877 - AB FLEX: 2020-06-29 EMS Belt
• 06972946644133 - AB FLEX: 2020-06-29 EMS Belt
• 06972946644652 - AB FLEX: 2020-06-29 EMS Belt
• 06972946645062 - AB FLEX: 2020-06-29 EMS Belt