Minuteful-kidney test
Healthy.Io, Ltd.
HEALTHY.IO LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015921024 | 3015921024 | HEALTHY.IO LTD. | 1 | N | 2026-01-01 | 40, Ha-Masger Tel Aviv-Yafo IL 6721122 |
| 3016241189 | 3016241189 | Healthy.io (US), Inc. | 1 | Y | 2020-04-25 | 1007 N. Orange Street, 4th Floor MWE Corporate Services, LLC. Wilmington DE US 19801 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 237187 | 1885853088 | K222921 | Minuteful-kidney test | JIR | 2023-09-08 |
| 237187 | 1436794364 | K210069 | Minuteful - kidney test | JIR | 2022-07-06 |
| 237187 | 1801454320 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JIR | 2 | 2023-09-08 |
PMN#
Minuteful - Kidney Test
Healthy.io Ltd.
ACR LAB Urine Analysis Test System
Healthy.io Ltd
DIP/U.S. Urine Analysis Test System
Healthy.io Ltd
GUDID#
Minuteful for Wound at Home - The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
2024-03-01
Minuteful for Wound - The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
2024-03-01
SPOT - The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
2020-08-25
Minuteful for Wound - The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
2022-09-15
SPOT - The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
2022-01-17
Minuteful - kidney test - The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
2022-11-01
SPOT - The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
2022-01-17