510(k) K253638
- Device
- xStep (xStep)
- Applicant
- Spinex, Inc.
- 510(k) number
- K253638
- Product code
- SDO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-20
- Date received
- 2025-11-19
- Regulation
- 890.5851
- Classification name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Parag Gad
- Address
- 37917 Lavender Commons Fremont CA US 94536 94536
FDA Registration Numbers#
- 3034209955
- 3045321552
- 3034211447
- 3027062639
Source Documents#
Other 510(k) Records For Product Code SDO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |