FDA.reportPublic FDA data

eMotus

Primary DI
00850065937403
Brand
eMotus
Company
EMPNIA INC.
Model
EMP106
Catalog number
EMP106
Device description
Respiratory Management System - Mevion
Published
2026-10-27
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
00850065937403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065937403008500659374038500659374030850065937403

GMDN Terms#

Term, Definition table
TermDefinition
Breath-hold systemAn assembly of portable electronic devices designed to provide bio-feedback to a patient to indicate when they should hold their breath during a procedure requiring precise location of target tissues potentially compromised by respiratory motion. It typically consists of a base station, multiple remote (wireless) displays that provide feedback to the patient and healthcare staff, patient respiration belts, and software. It is used for image-guided biopsy procedures, radio-frequency (RF) ablation, cryoablation, marker introduction, and often in conjunction with radiological systems, e.g., computed tomography (CT) and/or imaging ultrasound (US).

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
false
Serial number
true
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
00850065937410eMotusEMP031EMP0312026-10-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.LHN2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21