Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.

• Trade Name: TheraBionic P1
• Generic Name: stimulator, electric field, intrabuccal
• Applicant: TheraBionic, Inc.; 4108 ryan way; winston-salem, NC 27106-3567
• HDE Number: H220001
• Supplement Number: S001
• Date Received: 09/28/2023
• Decision Date: 12/11/2023
• Product Code: QOM [ Registered Establishments with QOM ]
• Advisory Committee: General & Plastic Surgery
• Clinical Trials: NCT00534664; NCT04327700
• Supplement Type: normal 75 day track
• Supplement Reason: request for adn
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for an adn and the ability to make a profit.