FDA.reportPublic FDA data

Wireless PLM/EMG sensor right leg

Primary DI
04250413410392
Brand
Wireless PLM/EMG sensor right leg
Company
SOMNOmedics AG
Model
NGS075
Published
2026-10-08
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
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201054000SOMNOscreen plusSomnomedics GmbH2020-08-12OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250413410392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413410392042504134103924250413410392

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00

Regulatory Flags#

DUNS number
314112173
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
false
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
04250413401635DOMINO lightSOW1052026-10-07
04250413402861EEG-ElectrodeSEN0072026-10-07
04250413404858SOMNOtouch™ RESP ecoTOR050-E-U2026-10-07
04250413405657ABPMpro SoftwareSW1002026-10-07
04250413405664DOMINOSSC0902026-10-07
04250413410385Wireless PLM/EMG sensor left legNGS0742026-10-07
04250413405725HomeSleepTestHST050U2026-07-02
04250413405732HomeSleepTest REM+HSTR050U2026-07-02
04250413410637SOMNOscreen HDNGD050U2026-08-13
04250413402724SOMNOscreen ecoNGN050U2019-03-15
04250413403578Cuff ABPMpro without ECGABP501/B2026-07-07
04250413403585Cuff ABPMpro without ECGABP502/B2026-07-07
04250413406388SOMNOwatch™ eco orangeSOWE050-O2026-07-07
04250413406456Cuff ABPMpro for right armABP500R2026-07-07
04250413406463Cuff ABPMpro for right armABP501R2026-07-07
04250413406470ABPMpro cuff for right armABP502R2026-07-07
04250413402748SOMNOwatch plus ACTISOWP100Z2023-12-07
04250413402755SOMNOwatch plus ACTISOWP200Z2023-12-07
04250413401475SOMNOwatch plus ACTISOWP2002019-04-12
04250413401666SOMNOwatch plus Docking StationSOW1062019-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413401635DOMINO lightSOMNOmedics AGMNR2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGMNR2026-10-07
04250413404858SOMNOtouch™ RESP ecoSOMNOmedics AGMNR2026-10-07
04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
04250413410385Wireless PLM/EMG sensor left legSOMNOmedics AGMNR2026-10-07
00850063034395Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034500Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034517Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00860000272421Rhythm ExpressVIVAQUANT, INC.MNR2026-10-01
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25
04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
04250413406388SOMNOwatch™ eco orangeSOMNOmedics AGMNR2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGMNR2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGMNR2026-07-02
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15