Digital tens dual channel

GUDID 04716770005805

BESMED HEALTH BUSINESS CORP.

Physical therapy electrical stimulation system, line-powered

• Primary Device ID: 04716770005805
• NIH Device Record Key: 30dca6d4-8d40-4b60-8fea-340328309597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital tens dual channel
• Version Model Number: BE-580
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770005805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031375

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2016-09-07

On-Brand Devices [Digital tens dual channel]

• 04716770926605: BE-92660
• 04716770925806: DIGITAL TENS DUAL CHANNEL
• 04716770005805: BE-580