FDA.reportPublic FDA data

Gateway

Primary DI
08051122041015
Brand
Gateway
Company
NCS LAB SRL
Model
GTWY01
Device description
The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inertial sensor.
Published
2022-03-14
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
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051122041015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051122041015080511220410158051122041015

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39059669813quality@ncs-company.com

Regulatory Flags#

DUNS number
429763668
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051122041138Elite Spk inserterP005_AS034_132022-06-09
08051122040988GT TUNNELERGTTN00M12022-06-03
08051122041091Software web ShowmotionSHWM01SW12022-03-14
08051122040902Shoulder Pacemaker deviceSPM01M1SPM01M12021-09-01
08051122040919Shoulder Pacemaker device (wireless PC)SPM01M2SPM01M22021-09-01
08051122040926MySPM AppSPM01A1SPM01A12021-09-01
08051122040933MySPM@Home AppSPM01A2SPM01A22021-09-01
08051122040940Stand-alone mode KitSPM01K1SPM01K12021-09-01
08051122040957Wireless mode - KitSPM01K2SPM01K22021-09-01
08051122040964Wireless app mode - KitSPM01K3SPM01K32021-09-01
08051122040971Wireless app home mode - KitSPM01K4SPM01K42021-09-01
08051122041190Taylor Stitcher Sterilization basketP005_AS034_092022-06-09
08051122040698TAYLOR STITCHERP005_AS0342022-06-09
08051122041121Taylor Stitcher bodyP005_AS034_012022-06-09
08051122041145Taylor Stitcher PunchP005_AS034_032022-06-09
08051122041152Taylor Stitcher ScrewdriverP005_AS034_042022-06-09
08051122041169Taylor Stitcher Targeting systemP005_AS034_052022-06-09
08051122041176Taylor Stitcher Screw ring main bodyP005_AS034_062022-06-09
08051122041183Taylor Stitcher ScrewsP005_AS034_082022-06-09
08051122041206Taylor Stitcher HammerP005_AS034_122022-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
G186EXERSCAN30Exer ScanExer Labs, Inc.ISD2025-11-10
00860004615606XR Therapy SystemNeuromersive, Inc.ISD2025-10-25
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
00850064651058DS6Foresite Healthcare, LLCISD2024-05-24
00850064651065DS6Foresite Healthcare, LLCISD2024-05-24
00815948029460REAL y-SeriesPENUMBRA, INC.ISD2024-04-16
00815948029477REAL y-SeriesPENUMBRA, INC.ISD2024-04-16
00815948029484REAL y-SeriesPENUMBRA, INC.ISD2024-04-16