510(k) DEN180057
DEN180057 is an FDA 510(k) premarket notification submitted by Innovative Health Solutions (Ihs), Inc. for the device "IB-Stim". The FDA issued a decision of De Novo Granted on June 7, 2019. The device falls under product code QHH (Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)), a Class II device regulated under 21 CFR 876.5340. Innovative Health Solutions (Ihs), Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 7, 2019
- Date Received
- October 25, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
- Device Class
- Class II
- Regulation Number
- 876.5340
- Review Panel
- GU
- Submission Type
A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.