IB-Stim

Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)

Innovative Health Solutions (IHS), Inc.

The following data is part of a De Novo classification by Innovative Health Solutions (ihs), Inc. with the FDA for Ib-stim.

Pre-market Notification Details

DeNovo IDDEN180057
Device Name:IB-Stim
ClassificationNon-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
Applicant Innovative Health Solutions (IHS), Inc. 829 South Adams St. Versailles,  IN  47042
ContactTom Carrico
Product CodeQHH  
CFR Regulation Number876.5340 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2018-10-25
Decision Date2019-06-07
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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