HDE supplement
H220001 S002: TheraBionic P1
FDA HDE supplement · normal 75 day track · TheraBionic, Inc.
Key facts
| Original HDE | H220001 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| Reason for the supplement | postapproval study protocol |
| Trade name | TheraBionic P1 |
| Generic name | Stimulator, electric field, intrabuccal |
| Applicant | TheraBionic, Inc. |
| Product code | QOM |
| Received date | Oct 25, 2023 |
| Decision date | Jul 17, 2024 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: