FDA product code SDO: Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
SDO is the FDA product code for transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation. It is a Class II device, regulated under 21 CFR 890.5851 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under SDO, 3 in the last five years, from 3 different applicants. The average 510(k) review took 168 days (median 154); 164 days on average over the last three years. 1 De Novo request was granted under it.
Definition
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
| Field | Value |
|---|---|
| Device name | Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation |
| Device class | Class II |
| Regulation | 21 CFR 890.5851 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for SDO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 154 |
| 2026 | 2 | 174 |
Compare with all 510(k) review times · Search every SDO clearance
Top SDO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spinex, Inc. | 1 | 2026-04-20 |
| Aneuvo | 1 | 2026-03-27 |
| Onward Medical, Inc. | 1 | 2025-11-14 |
Most recent SDO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253638 | Spinex, Inc. | xStep (xStep) | 2026-04-20 | 152 |
| K252893 | Aneuvo | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | 2026-03-27 | 197 |
| K251821 | Onward Medical, Inc. | ARC-EX System | 2025-11-14 | 154 |
Recalls for SDO devices
openFDA lists no recalls for product code SDO.
Frequently asked questions
What is FDA product code SDO?
SDO is the FDA product code for transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation. It is a Class II device, regulated under 21 CFR 890.5851 and reviewed by the Physical Medicine panel.
What device class is SDO?
Class II, regulation 21 CFR 890.5851. Typical premarket route: 510(k).
How long does a 510(k) take for product code SDO?
Across 3 cleared submissions the average was 168 days from receipt to decision (median 154).
Which companies have the most SDO clearances?
Spinex, Inc. (1); Aneuvo (1); Onward Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SDO
- Run a recall and safety report across every SDO manufacturer
- Watch product code SDO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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