TheraBionic P1
- Primary DI
- 04251867200072
- Brand
- TheraBionic P1
- Company
- TheraBionic GmbH
- Model
- THBC P1 1.1-US-HDE
- Catalog number
- THBC P1 1.1-US-HDE
- Published
- 2024-02-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QOM | Stimulator, Electric Field, Intrabuccal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QOM | Stimulator, Electric Field, Intrabuccal | | |
Premarket Submissions
| Submission | Supplement |
|---|
| H220001 | 000 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| H220001 | 000 | | | | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04251867200072 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Alternating electric field antimitotic cancer treatment system generator | A portable, battery-powered component of an alternating electric field cancer treatment system designed to generate intermediate-frequency (100-300 kHz) alternating electric current to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Also known as tumour treatment fields (TTFields) or (TTF), the treatment is usually intended to be used as a home-use supplement to primary therapies (e.g., surgery, radiotherapy, and/or chemotherapy). Designed to be carried by the patient it is powered by a rechargeable battery pack or via a mains power supply and is connected to a head-worn transducer array via a connection cable. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 700 millibar | 1200 millibar | |
| Handling Environment Humidity | 0 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Handling Environment Temperature | -20 Degrees Celsius | 60 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| 312 286 4703 | boris.pasche@therabionic.de |
Regulatory Flags
- DUNS number
- 312894281
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 04251867200126 | TheraBionic P1 | THBC P1-S-04 | THBC P1-S-04 | 2025-06-04 |
| 04251867200089 | Therabionic P1 | 05 | THBC P1-TU-1.1 | 2024-04-24 |
| 04251867200119 | Therabionic P1 | 02 | THBC P1-PS-02 | 2024-04-24 |
| 04251867200096 | Docking station TheraBionic P1 | 07 | THBC P1-DS-1.1 | 2024-04-23 |
| 04251867200102 | Patient spoon with connecting cable TheraBionic P1 - Version 3 | 03 | THBC P1-S-03 | 2024-04-23 |
Other Devices Sharing Product Codes