Digital tens one channel

GUDID 04716770005607

BESMED HEALTH BUSINESS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04716770005607
• NIH Device Record Key: f523f01d-6a27-4a9f-b711-30960e548785
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital tens one channel
• Version Model Number: BE-560
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770005607 [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: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-07

On-Brand Devices [Digital tens one channel]

• 04716770925509: BE-92550
• 04716770005607: BE-560