Product Code: SHX
FDA class 2
21 CFR 882.5807
Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms
Neurology
510(k)s
1
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SHX
- Device Class
- FDA class 2
- Regulation Number
- 882.5807
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patients head. The device is not intended as a stand-alone therapy or to alter usual care treatment.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN250013 | Modius Spero | May 08, 2026 | Unknown | Neurovalens Limited |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.