Portable Neuromodulation Stimulator (PoNS)
FDA 510(k) clearance K253061 · decided 2026-05-13
Clearance details
- K-number
- K253061
- Device name
- Portable Neuromodulation Stimulator (PoNS)
- Applicant
- Helius Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-22
- Decision date
- 2026-05-13
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- QCF
- Device class
- 2
- Regulation number
- 882.5889
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Newton, PA, 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 |
|---|---|---|
| Portable Neuromodulation Stimulator (PoNS) (DEN200050) | Helius Medical, Inc. | 2021-03-26 |
Recalls involving this device
No recalls on record reference this clearance.