Prelivia Lead Bulk PR-LEAD1B

GUDID 17540176050046

Pack of 10 Leads

Rehabtronics Inc

Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 17540176050046
• NIH Device Record Key: 21d3708c-e960-469e-ab14-4051a9cc1eb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelivia Lead Bulk
• Version Model Number: PR-LEAD1B
• Catalog Number: PR-LEAD1B
• 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: 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	17540176050046 [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: 2021-10-12
• Device Publish Date: 2021-10-04

Devices Manufactured by Rehabtronics Inc

• 17540176030147 - ReGrasp: 2024-03-04 ReGrasp Electrode Positioning Kit Version 2
• 17540176030154 - ReGrasp: 2024-03-04 ReGrasp HMS Button Control
• 17540176030161 - ReGrasp: 2024-03-04 ReGrasp Garment Liners (small)
• 17540176030178 - ReGrasp: 2024-03-04 ReGrasp Garment Liners (medium)
• 17540176030185 - ReGrasp: 2024-03-04 ReGrasp Garment Liners (large)
• 17540176030192 - ReGrasp: 2024-03-04 EPK Transfer Sheet
• 17540176030208 - ReGrasp: 2024-03-04 EPK Pens
• 17540176030215 - ReGrasp: 2024-03-04 EPK Large Gel Electrodes