FDA.reportPublic FDA data

DataLITE LE230 Wireless EMG Sensor

Primary DI
05060481690638
Brand
DataLITE LE230 Wireless EMG Sensor
Company
BIOMETRICS LIMITED
Model
LE230
Device description
The DataLITE wireless surface EMG sensor gives superb quality of signal and ease of use. With a bandwidth of 5-495 Hz and a built in 1000 gain amplifier and wireless transmitter, surface EMG signals are collected and sent to the Biometrics software for analysis. EMG data can be synchronized real-time with other sensors as part of a complete DataLITE system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
Published
2018-08-09
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060481690638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060481690638050604816906385060481690638

GMDN Terms#

Term, Definition table
TermDefinition
Electromyography telemetric monitoring system transmitterA body-worn, battery-powered component of an electromyography telemetric monitoring system designed to continuously measure and wirelessly transmit electromyographic (EMG) signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
519969810
Device count
1
Premarket exempt
true
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.HCC2026-06-04
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.HCC2026-04-22
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
06970670070334XFTShenzhen XFT Medical LimitedHCC2026-04-14
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020483UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30