510(k) K253061
- Device
- Portable Neuromodulation Stimulator (PoNS)
- Applicant
- Helius Medical, Inc.
- 510(k) number
- K253061
- Product code
- QCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-13
- Date received
- 2025-09-22
- Regulation
- 882.5889
- Classification name
- Electrical Tongue Stimulator To Treat Motor Deficits
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lawrence Picciano
- Address
- 642 Newtown Yardley Rd. Suite 100 Newton PA US 18940 18940
FDA Registration Numbers#
- 3015259856
- 3036471706
Source Documents#
Other 510(k) Records For Product Code QCF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN200050 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | 2021-03-26 |