FDA.reportPublic FDA data

MY01 Mobile Application

Primary DI
07540162030093
Brand
MY01 Mobile Application
Company
MY01 Inc
Model
v1.22
Catalog number
MY01-APP
Published
2025-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXCMonitor, Pressure, Intracompartmental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXCMonitor, Pressure, IntracompartmentalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242997000MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2025-03-13LXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540162030093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540162030093075401620300937540162030093

GMDN Terms#

Term, Definition table
TermDefinition
Compartmental-pressure monitoring system, single-useAn assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., a prefilled syringe, one-way valves, and a side ported noncoring needle and/or slit catheter). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203869834
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540162030017MY01 Continuous Compartmental Pressure Monitor0001MY01-00012021-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G247CPMX10CPMX1Compremium AGLXC2025-05-19
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10850007350182Side Ported Needle - 20GC2DX, INC.LXC2022-05-03