510(k) K230526
K230526 is an FDA 510(k) premarket notification submitted by Transtimulation Research, Inc. for the device "TEA Device". The FDA issued a decision of Substantially Equivalent on September 14, 2023. 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. Transtimulation Research, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2023
- Date Received
- February 27, 2023
- 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.