Therabionic P1
- Primary DI
- 04251867200119
- Brand
- Therabionic P1
- Company
- TheraBionic GmbH
- Model
- 02
- Catalog number
- THBC P1-PS-02
- Device description
- AC power supply unit, 15W for the TheraBionic P1 - Variant 2
- Published
- 2024-04-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|
| 04251867200119 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04251867200119 | 04251867200119 | 4251867200119 |
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 |
|---|
| Special Storage Condition, Specify | 0 | 0 | Temperature range of -20°C - +60°C, humidity range of 0% - 90%, pressure range of 700hPa - 1200 hPa |
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
- true
- 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 |
| 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 |
| 04251867200072 | TheraBionic P1 | THBC P1 1.1-US-HDE | THBC P1 1.1-US-HDE | 2024-02-09 |
Other Devices Sharing Product Codes
therabionic.de