Product code SDO
- Device name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5851
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K253638 | xStep (xStep) | Spinex, Inc. | 2026-04-20 |
| K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | Aneuvo | 2026-03-27 |
| K251821 | ARC-EX System | Onward Medical, Inc. | 2025-11-14 |
| DEN240014 | ARC-EX System | Onward Medical, Inc. | 2024-12-19 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 08720908310033 | ARC-EX System | ONWARD Medical N.V. | 2025-12-05 |
| 08720908310040 | ARC-EX System | ONWARD Medical N.V. | 2024-12-27 |