Prelivia

GUDID 17540176050008

The Prelivia System is a portable transcutaneous muscle stimulation system intended to increase regional blood circulation at stimulated treatment areas, and to reduce the incidence and progression of pressure ulcers (bed sores) in individuals who are immobile due to their clinical condition. The system consists of a battery

Rehabtronics Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 17540176050008
• NIH Device Record Key: 1b1a6467-e5ac-4409-bf36-e02c63d7520c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelivia
• Version Model Number: PR-IES1
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17540176050008 [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: 2021-10-11
• Device Publish Date: 2021-10-01

On-Brand Devices [Prelivia]

• 17540176050008: The Prelivia System is a portable transcutaneous muscle stimulation system intended to increase
• 17540176050091: The Prelivia System is a portable transcutaneous muscle stimulation system intended to increase