Portable Neuromodulation Stimulator (PoNS)
FDA 510(k) clearance DEN200050 · decided 2021-03-26
Clearance details
- K-number
- DEN200050
- Device name
- Portable Neuromodulation Stimulator (PoNS)
- Applicant
- Helius Medical, Inc.
- Decision
- Unknown
- Date received
- 2020-08-04
- Decision date
- 2021-03-26
- Days to decision
- 234 days
- Clearance type
- Direct
- 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
+ Add to Predicate Builder ◉ Watch Helius Medical
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 |
|---|---|---|
| Portable Neuromodulation Stimulator (PoNS) (K253061) | Helius Medical, Inc. | 2026-05-13 |
Recalls involving this device
No recalls on record reference this clearance.