xStep (xStep)
FDA 510(k) clearance K253638 · decided 2026-04-20
Clearance details
- K-number
- K253638
- Device name
- xStep (xStep)
- Applicant
- Spinex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-19
- Decision date
- 2026-04-20
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- SDO
- Device class
- 2
- Regulation number
- 890.5851
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Spinex
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (K252893) | Aneuvo | 2026-03-27 |
| ARC-EX System (K251821) | Onward Medical, Inc. | 2025-11-14 |
| ARC-EX System (DEN240014) | Onward Medical, Inc. | 2024-12-19 |
Recalls involving this device
No recalls on record reference this clearance.