FDA.reportPublic FDA data

E-LINK Myo-EX GX4 EMG Sensor

Primary DI
05060481690515
Brand
E-LINK Myo-EX GX4 EMG Sensor
Company
BIOMETRICS LIMITED
Model
GX4
Catalog number
GX4 metal connector
Device description
Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement.GX4 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles..Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors.This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
Published
2018-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060481690515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060481690515050604816905155060481690515

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
519969810
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060481690454E-LINK Software (Version 16)16xx-xxx-xxxx2018-08-09
05060481691420SX230-1000 EMG SensorSX230-1000bandwidth 20-460 plastic connector2018-08-09
05060481691437SX230-1000 EMG SensorSX230-1000bandwidth 5-480 plastic connector2018-08-09
05060481691444SX230-1000 EMG SensorSX230-1000bandwidth 5-1000 plastic connector2018-08-09
05060481691451SX230-100 EMG SensorSX230-100Gain 100, bandwidth 20-460 plastic connector2018-08-09
05060481691468SX230FW EMG SensorSX230FWbandwidth 20-460 plastic connector2018-08-09
05060481691475SX230-1000 EMG SensorSX230-1000bandwidth 20-460 metal connector2018-08-10
05060481691482SX230-1000 EMG SensorSX230-1000bandwidth 5-480 metal connector2018-08-10
05060481691499SX230-1000 EMG SensorSX230-1000bandwidth 5-1000 metalconnector2018-08-10
05060481691505SX230-100 EMG SensorSX230-100Gain 100, bandwidth 20-460 metal connector2018-08-10
05060481691512SX230FW EMG SensorSX230FWbandwidth 20-460 metal connector2018-08-10
05060481690003E-LINK X4 Interface UnitX4X4 MkIV plastic connectors2018-02-14
05060481690195E-LINK DG1 Wireless DongleDG12018-08-09
05060481690201E-LINK CA1 Battery ChargerCA12018-08-09
05060481690218E-LINK AD1 Wireless AdaptorAD12018-08-09
05060481690492E-LINK X4 Interface UnitX4X4 MkII metal connectors2018-08-09
05060481690607DataLITE DG2 Wireless DongleDG22018-08-09
05060481690614DataLITE CA2 Battery ChargerCA22018-08-09
05060481690621DataLITE AD2 Wireless AdaptorAD22018-08-09
05060481692465E-LINK EX2 Interface Unit for M400EX22018-08-10

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