FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QOMStimulator, Electric Field, Intrabuccal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOMStimulator, Electric Field, Intrabuccal

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H220001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H220001000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251867200072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251867200072042518672000724251867200072

GMDN Terms#

Term, Definition table
TermDefinition
Alternating electric field antimitotic cancer treatment system generatorA 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 table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1200 millibar
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
312 286 4703boris.pasche@therabionic.de

Regulatory Flags#

DUNS number
312894281
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251867200126TheraBionic P1THBC P1-S-04THBC P1-S-042025-06-04
04251867200089Therabionic P105THBC P1-TU-1.12024-04-24
04251867200119Therabionic P102THBC P1-PS-022024-04-24
04251867200096Docking station TheraBionic P107THBC P1-DS-1.12024-04-23
04251867200102Patient spoon with connecting cable TheraBionic P1 - Version 303THBC P1-S-032024-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251867200126TheraBionic P1TheraBionic GmbHQOM2025-06-04
04251867200089Therabionic P1TheraBionic GmbHQOM2024-04-24
04251867200119Therabionic P1TheraBionic GmbHQOM2024-04-24
04251867200096Docking station TheraBionic P1TheraBionic GmbHQOM2024-04-23
04251867200102Patient spoon with connecting cable TheraBionic P1 - Version 3TheraBionic GmbHQOM2024-04-23