FDA.reportPublic FDA data

eMotus

Primary DI
00850065937397
Brand
eMotus
Company
EMPNIA INC.
Model
EMP126
Catalog number
EMP126
Device description
HDMI to USB-C Adapter w USB-A
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243900000eMotus Respiratory Motion Management SystemEmpnia, Inc.2025-06-27LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065937397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065937397008500659373978500659373970850065937397

GMDN Terms#

Term, Definition table
TermDefinition
Breath-hold system remote displayA non-sterile, battery-powered component of a breath-hold system designed as the patient interface display, via a system of indicators [e.g., light-emitting diodes (LEDs)], to instruct the patient when and how long to hold their breath for scheduled breath holds. It receives wirelessly the electronic bio-feedback sequences from the system's base station and is situated in the viewing line of the patient. This is a reusable device.

Regulatory Flags#

DUNS number
119402293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065937007eMotusEMP001EMP0012026-09-21
00850065937014eMotusEMP002EMP0022026-09-21
00850065937021eMotusEMP101EMP1012026-09-21
00850065937038eMotusEMP102EMP1022026-09-21
00850065937045eMotusEMP103EMP1032026-09-21
00850065937052eMotusEMP104EMP1042026-09-21
00850065937069eMotusEMP000EMP0002026-09-21
00850065937076eMotusEMP003EMP0032026-09-21
00850065937083eMotusEMP004EMP0042026-09-21
00850065937090eMotusEMP005EMP0052026-09-21
00850065937106eMotusEMP020EMP0202026-09-21
00850065937113eMotusEMP015EMP0152026-09-21
00850065937120eMotusEMP016EMP0162026-09-21
00850065937137eMotusEMP012EMP0122026-09-21
00850065937144eMotusEMP018EMP0182026-09-21
00850065937151eMotusEMP006EMP0062026-09-21
00850065937168eMotusEMP010EMP0102026-09-21
00850065937175eMotusEMP019EMP0192026-09-21
00850065937182eMotusEMP021EMP0212026-09-21
00850065937199eMotusEMP007EMP0072026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.LHN2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.LHN2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.LHN2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.LHN2026-09-21