INF 4160C

GUDID 04897079950017

BRACEMART, LLC

Interferential electrical stimulation system

• Primary Device ID: 04897079950017
• NIH Device Record Key: 565f0f7e-b07f-4d1a-a8d0-ed7f3816085a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INF 4160C
• Version Model Number: 1
• Company DUNS: 055605293
• Company Name: BRACEMART, LLC
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897079950017 [Primary]
GS1	14897079950014 [Package]; Package: Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092780

FDA Product Code

• LIH: Interferential Current Therapy

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: 2016-12-16