FDA.reportPublic FDA data

K800 Amplifier

Primary DI
05060481692199
Brand
K800 Amplifier
Company
BIOMETRICS LIMITED
Model
K800
Device description
A modern microprocessor controlled general purpose amplifier system which is designed to be worn by the subject. The Amplifier (K800) provides a user friendly method for collecting signals from a variety of sensors including goniometers, sEMG and related signals, in a format which may readily be connected to proprietary display and recording systems including A/D cards.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
IKKSystem, Isokinetic Testing And Evaluation
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060481692199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060481692199050604816921995060481692199

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

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
08600157703018TGCT & MeREMEPY HEALTH LTDKQX2026-05-24
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06975343590027Lower Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590034Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590041Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590058Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590065Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590072Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590089Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590218Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
04041925006339PHS - XSmedica - Medizintechnik GmbHIKK2026-05-13
04041925006346PHS - Smedica - Medizintechnik GmbHIKK2026-05-13
04041925006353PHS - Mmedica - Medizintechnik GmbHIKK2026-05-13
04041925006360PHS - Lmedica - Medizintechnik GmbHIKK2026-05-13
04041925006377PHS - XLmedica - Medizintechnik GmbHIKK2026-05-13
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00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30