HDE
H220001: TheraBionic P1
FDA Humanitarian Device Exemption · TheraBionic, Inc.
Key facts
| HDE number | H220001 |
|---|---|
| Trade name | TheraBionic P1 |
| Generic name | Stimulator, electric field, intrabuccal |
| Applicant | TheraBionic, Inc. |
| Owner/operator | TheraBionic GmbH |
| Product code | QOM |
| Approval date | Sep 26, 2023 |
| Establishment registration | 3015593319 |
| FEI number | 3015593319 |
At a glance
- 1–9 Supplements
- Jul 28, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: