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Found 4 results
510(k) Data Aggregation
K Number
K251500Device Name
MallyaG Injection Pen Adapter (MallyaG)
Manufacturer
Biocorp Production
Date Cleared
2025-06-09
(25 days)
Product Code
QOG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Biocorp Production
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors.
The Novo Nordisk PDS290 Injection pens compatible for growth disorder treatment are:
- Sogroya (somapacitan-beco)
- Norditropin FlexPro
Device Description
The MallyaG Injection Pen Adapter is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the MallyaG device, is also provided in the package. The information is captured through the rotation of the dosing button of the pen into a value indicating the dose increment injected.
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K Number
K250555Device Name
MallyaD injection pen adapter (MallyaD)
Manufacturer
BioCorp Production
Date Cleared
2025-03-27
(30 days)
Product Code
QOG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BioCorp Production
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MallyaD Injection Pen Adapter is indicated for the capture and wireless transmission of compatible reusable and disposable pen injectors.
The Novo Nordisk PDS290 Injection pens compatible for diabetes treatment are:
- insulin degludec molecule (Tresiba U-100 FlexTouch and Tresiba U-200 FlexTouch)
- insulin aspart molecule (Fiasp FlexTouch)
- insulin degludec and liraglutide molecules (Xultophy)
Device Description
The concerned Mallya Injection Pen Adapter, also called Mallyaº, is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the Mallya® device is also provided in the package.
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K Number
K231820Device Name
SoloSmart Injection Pen Adapter (SoloSmart®)
Manufacturer
Biocorp Production
Date Cleared
2024-01-12
(205 days)
Product Code
QOG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Biocorp Production
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
Device Description
The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package.
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K Number
K222689Device Name
Mallya Injection Pen Adapter (Mallya® for Solostar®)
Manufacturer
Biocorp Production
Date Cleared
2022-12-05
(90 days)
Product Code
QOG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Biocorp Production
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mallya Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
Device Description
The device is made of two parts to be assembled onto a pen injector. The Mallya base part (about 6 x 3 x 2 cm) which clips around the body of the injection pen and the Mallya button (about 2.5 x Ø2 cm) that slips over the injection pen button. A USB cable, necessary to charge the MALLYA device, and a reset key are also provided in the package.
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