510(k) K202940
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2020
- Date Received
- September 30, 2020
- Clearance Type
- Traditional
- 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.