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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 NameTheraBionic P1
Generic Namestimulator, electric field, intrabuccal
Applicant
Therabionic, Inc.
4108 ryan way
winston-salem, NC 27106
HDE NumberH220001
Supplement NumberS004
Date Received03/13/2026
Decision Date05/27/2026
Product Code
QOM[ Registered Establishments with QOM ]
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00534664
NCT04327700
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for proposed labeling changes and additional contraindications for the therabionic p1.
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