ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
FDA 510(k) clearance K252893 · decided 2026-03-27
Clearance details
- K-number
- K252893
- Device name
- ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
- Applicant
- Aneuvo
- Decision
- Substantially Equivalent
- Date received
- 2025-09-11
- Decision date
- 2026-03-27
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- SDO
- Device class
- 2
- Regulation number
- 890.5851
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| xStep (xStep) (K253638) | Spinex, Inc. | 2026-04-20 |
| 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.