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, a class II device type, regulated under 21 CFR 890.5851. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SDO
- Device name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- FDA 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.
- Regulation
- 21 CFR 890.5851
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code SDO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 2 |
Applicants with the most clearances
Product code SDO| Applicant | Clearances |
|---|---|
| ONWARD Medical Inc. | 2 |
| Aneuvo | 1 |
| Spinex, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
