Device class
Class II
Regulation 876.5340
Total clearances
5
2020-12-29 → 2025-10-16
Definition
What is Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
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.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.5340
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Neuraxis
|
3 |
1 |
2025-10-16 |
|
Transtimulation Research, Inc. |
1 |
0 |
2023-09-14 |
|
Dyansys, Inc.
|
1 |
0 |
2020-12-29 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| E0720 |
HCPCS
|
Transcutaneous electrical nerve stimulation (tens) device, two lead, localized stimulation ✓ CMS-verified description |
High
|
Transcutaneous electrical nerve stimulator; standard HCPCS code for non-implanted TENS devices |
| 64550 |
CPT
|
— |
Medium
|
Transcutaneous electrical nerve stimulation (TENS); non-implanted nerve stimulation for pain |
| 64565 |
CPT
|
— |
Medium
|
Percutaneous electrode placement; if device includes electrode placement for abdominal nerve stimulation |
Pulse
Most recent 510(k) clearances