Device class
Class II
Regulation 890.5851
Total clearances
4
2024-12-19 → 2026-04-20
Definition
What is Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.
Classification details
Medical specialty
Physical Medicine
Regulation number
890.5851
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Onward Medical, Inc. |
2 |
1 |
2025-11-14 |
|
Spinex, Inc. |
1 |
1 |
2026-04-20 |
|
Aneuvo |
1 |
1 |
2026-03-27 |
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 |
| 64553 |
CPT
|
— |
Medium
|
Percutaneous/transcutaneous spinal cord stimulator electrode placement |
| 64555 |
CPT
|
— |
Medium
|
Transcutaneous stimulation for pain/strength/sensation over spinal region |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-04-20 |
K253638 |
Spinex, Inc.
|
xStep (xStep) |
| 2026-03-27 |
K252893 |
Aneuvo
|
ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) |
| 2025-11-14 |
K251821 |
Onward Medical, Inc.
|
ARC-EX System |
| 2024-12-19 |
DEN240014 |
Onward Medical, Inc.
|
ARC-EX System |