RS-LBG-O Low Back Garment Only

GUDID 00850814007203

RS-LBG Low Back Garment Only and treatment electrodes

R S Medical

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00850814007203
• NIH Device Record Key: 5bed0098-924c-4a09-bd76-d39761020465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RS-LBG-O Low Back Garment Only
• Version Model Number: 959-0057-00
• 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	00850814007203 [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: 2024-02-14
• Device Publish Date: 2024-02-06

Devices Manufactured by R S Medical

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• 00850814007203 - RS-LBG-O Low Back Garment Only: 2024-02-14RS-LBG Low Back Garment Only and treatment electrodes
• 00850814007203 - RS-LBG-O Low Back Garment Only: 2024-02-14 RS-LBG Low Back Garment Only and treatment electrodes
• 00850814007210 - RS-FBG-O Full Back Garment Only: 2024-02-14 RS-FBG Full Back Garment Only and treatment electrodes
• 00850814007142 - RS-CLBG Conductive Low Back Garment: 2022-09-22 RS-LB Conductive Low Back Garment System, Snap adapter and treatment electrodes
• 00850814007159 - RS-CFBG Conductive Full Back Garment: 2022-09-22 RS-CFBG Conductive Full Back Garment System, Snap adapter and treatment electrodes
• 00850814007166 - RS-4s Muscle Stimulator System: 2022-09-22 RS-4s Muscle Stimulator System. Kit includes RS-4s Muscle Stimulator, treatment cable, rechargeable battery, battery charging do
• 00850814007173 - RS-SG Shoulder Garment: 2022-09-22 RS-SG Shoulder Garment with RS Stimulator Cable Set and treatment electrodes
• 00850814007180 - RS-4s Muscle Stimulator System (R): 2022-09-22 RS-4s Muscle Stimulator System. Refurbished Kit includes RS-4s Muscle Stimulator, treatment cable, rechargeable battery, battery