FDA.reportPublic FDA data

GBO MEDIZINTECHNIK AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050958603005095860GBO MEDIZINTECHNIK AG1N2026-01-01Kleiststrasse 6 Rimbach Hesse DE 64668

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3140141064148468K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF2026-06-02
3140141126226067K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)IPF2023-01-17
3140141262317847

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IPF22026-06-02

GUDID#