Prelivia Leads PR-LEAD1

GUDID 17540176050039

Leads for Prelivia

Rehabtronics Inc

Transcutaneous electrical stimulation electrode, single-use
Primary Device ID17540176050039
NIH Device Record Keyddd58f84-ef09-4acc-9b25-a39335a41ee2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelivia Leads
Version Model NumberPR-LEAD1
Catalog NumberPR-LEAD1
Company DUNS243936569
Company NameRehabtronics Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117540176050039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-12
Device Publish Date2021-10-04

Devices Manufactured by Rehabtronics Inc

17540176050091 - Prelivia2024-11-20 The Prelivia System is a portable transcutaneous muscle stimulation system intended to increase regional blood circulation at st
17540176050107 - Prelivia Electrode2024-11-20 2 Pairs
17540176050114 - Prelivia Electrode2024-11-20 20 Packs
17540176030147 - ReGrasp2024-03-04 ReGrasp Electrode Positioning Kit Version 2
17540176030154 - ReGrasp2024-03-04 ReGrasp HMS Button Control
17540176030161 - ReGrasp2024-03-04 ReGrasp Garment Liners (small)
17540176030178 - ReGrasp2024-03-04 ReGrasp Garment Liners (medium)
17540176030185 - ReGrasp2024-03-04 ReGrasp Garment Liners (large)

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