ARC-EX System
FDA 510(k) clearance DEN240014 · decided 2024-12-19
Clearance details
- K-number
- DEN240014
- Device name
- ARC-EX System
- Applicant
- Onward Medical, Inc.
- Decision
- Unknown
- Date received
- 2024-03-28
- Decision date
- 2024-12-19
- Days to decision
- 266 days
- Clearance type
- Direct
- Product code
- SDO
- Device class
- 2
- Regulation number
- 890.5851
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Boston, MA, 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.