Device
CT-132 (Selene) is a digital therapeutic smartphone app for patients with episodic migraine. It is intended to reduce monthly migraine days (MMDs). Selene requires a prescription f...
Manufacturer
Click Therapeutics, Inc.
Click Therapeutics, Inc.
Model: v2.x.x
DI: 00860003419021
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
CT-132 (Selene) is a digital therapeutic smartphone app for patients with episodic migraine. It is intended to reduce monthly migraine days (MMDs). Selene requires a prescription from a healthcare provider.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1a25c6b3-f313-4067-a732-5b1ba6ebef46
Distribution Status:
In Commercial Distribution
DUNS Number:
009577124
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860003419021
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63031
Name: Mental health/function therapeutic software, screen-viewed
Definition:
A screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading, speech) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically track development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient and may involve clinical assistance/recommendations.
FDA Product Codes
SEE
Computerized Behavioral Therapy Device For Migraine