RS-FBG Full Back Conductive Garment

GUDID 00850814007029

RS-FBG Full Back Conductive Garment System, RS-4i Plus Snap Cable Set and treatment electrodes

R S Medical

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00850814007029
• NIH Device Record Key: 02db14c4-3512-42d2-bb32-303df490b726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RS-FBG Full Back Conductive Garment
• Version Model Number: 959-0032-00
• Company DUNS: 625133228
• Company Name: R S Medical
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com
• Phone: 800-935-7763
• Email: cservice@rsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850814007029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090951

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2018-10-05
• Device Publish Date: 2018-09-04

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