FDA.reportPublic FDA data

eKare inSight

Primary DI
00860003459850
Brand
eKare inSight
Company
E-Kare Inc.
Model
EK001
Device description
System for wound measurement and management.
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXNTape, Camera, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXNTape, Camera, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003459850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003459850008600034598508600034598500860003459850

GMDN Terms#

Term, Definition table
TermDefinition
Wound measureA device designed to determine the dimensions of a wound typically to document changes in wound size during the healing process. The device may be a simple ruler or similar measuring device and/or a tracing film to outline a wound that may utilize an electronic digital tablet to calculate wound area or other dimensions (e.g., length, width, depth). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-443-5273info@ekareinc.com

Regulatory Flags#

DUNS number
079302040
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B376KB1000SnapshotGLOKent Imaging IncFXN2025-07-10
00860475000383Automated Wound MeasurementsEPIC SYSTEMS CORPORATIONFXN2025-02-03
09420071400010SilhouetteStarARANZ MEDICAL LIMITEDFXN2024-04-03
17290017272716Minuteful for WoundHEALTHY.IO LTDFXN2024-03-01
17290017272877Minuteful for Wound at HomeHEALTHY.IO LTDFXN2024-03-01
17290017272709Minuteful for WoundHEALTHY.IO LTDFXN2022-09-15
17290017272556SPOTHEALTHY.IO LTDFXN2022-01-17
07290017272504SPOTHEALTHY.IO LTDFXN2022-01-17
00628110259325MolecuLight i:X SystemMolecuLight IncFXN2022-01-04
00627987231144Swift VisionSwift Medical IncFXN2021-03-15
17290017272501SPOTHEALTHY.IO LTDFXN2020-08-25
00627987231090Swift Skin and Wound Swift Medical IncFXN2019-10-04
00627987231106PointClickCare Skin and WoundSwift Medical IncFXN2019-10-04
00627987231113Healogics Photo+Swift Medical IncFXN2019-10-04
00627987231137Medline NE1® WMSSwift Medical IncFXN2019-10-04
00850677007143PACS Scan MobileHYLAND LLCFXN2019-08-30
06953825902605Dr.meter®Shenzhen Urion Technology Co., LtdFXN2017-03-29