Prelivia Electrode PR-IES1A

GUDID 17540176050107

2 Pairs

Rehabtronics Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 17540176050107
• NIH Device Record Key: bf4ca6b2-1279-45de-b28c-a5c4d71661ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelivia Electrode
• Version Model Number: PR-EL1A
• Catalog Number: PR-IES1A
• Company DUNS: 243936569
• Company Name: Rehabtronics Inc
• 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: false
• 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	17540176050107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210979

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [Prelivia Electrode]

• 17540176050114: 20 Packs
• 17540176050107: 2 Pairs