BIOMETRICS LIMITED

Address:NINE MILE POINT IND. ESTATE,Newport Wales,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Exerciser, Measuring (ISD) (10) Device, Biofeedback (HCC) (3) Exerciser, Non-Measuring (ION) (3) Goniometer, Ac-Powered (KQX) (3) System, Isokinetic Testing And Evaluation (IKK) (3) Exerciser, Powered (BXB) (1)

Premarket Exempt

Yes

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E-LINK X4 Interface Unit - 05060481690003 Catalog Number : X4 MkIV plastic connectors

Device Description : The X4 InterX Unit functions as the intelligent interface to connect the E-LINK The X4 InterX Unit functions as the intelligent interface to connect the E-LINK evaluation and exercise modules to the computer via the USB port. Up to four E-LINK devices may be connected simultaneously allowing the user to easily and quickly switch between them during an evaluation or exercise session.Includes Medical Grade Power Supply and country specific mains power cord. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.

Device Class : 1

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : HCC, ISD, BXB, ION

Prescription Use : No

Device Count : 1

E-LINK Upper Limb Exerciser - 05060481690010 Catalog Number :

Device Description : "The E-LINK Upper Limb Exerciser is designed for active and active resistive upp "The E-LINK Upper Limb Exerciser is designed for active and active resistive upper extremity exercise of the wrist, forearm, elbow, and shoulder. The versatility of the parameters allows rehabilitation for a wide range of orthopedic and neurological patients.The Upper Limb Exerciser is available with either a wireless or wired interface to the computer."

Device Class : 1

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : ION, ISD

Prescription Use : No

Device Count : 1

Biometrics Ltd Dynamometer - 05060481690027 Catalog Number :

Device Description : The Biometrics Dynamometer utilises precision load cell technology to increase t The Biometrics Dynamometer utilises precision load cell technology to increase the sensitivity and accuracy of measurement of even very low grip strength forces. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

Device Class : 2

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : IKK, HCC, ISD

Prescription Use : No

Device Count : 1

Biometrics Ltd Pinchmeter - 05060481690034 Catalog Number :

Device Description : The unique electronic pinchmeter has a low profile design that enables the resea The unique electronic pinchmeter has a low profile design that enables the researcher to accurately quantify pinch strength at closer to end range than any other device. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.

Device Class : 2

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : HCC, ISD, IKK

Prescription Use : No

Device Count : 1

E-LINK Hand Kit - 05060481690041 Catalog Number :

Device Description : The E-LINK Hand Kit which includes a Dynamometer and Pinchmeter for monitoring g The E-LINK Hand Kit which includes a Dynamometer and Pinchmeter for monitoring grip and pinch strength, is the ideal module to quantify and monitor the effectiveness of various interventions for the upper extremity, throughout the whole rehabilitation process.The Hand Kit can also be used with the E-LINK Activities (Games), for innovative isometric grip and pinch exercises that are totally focused on the individual patient.The Hand Kit (H500) is available with either a wireless or wired interface

Device Class : 2

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : No

Device Count : 1

E-LINK N300 Small Goniometer - 05060481690058 Catalog Number :

Device Description : Accurate measurements of upper and lower extremity ROM with precise electronic t Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting.Hand (fingers and thumb) – active and passive, extension and flexion, abduction and adduction, lateral deviations and rotational deformities, calculation of total active motion and total passive motionWrist – active and passive, extension and flexion, radial and ulnar deviationThis product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

Device Class : 1

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : KQX, ISD

Prescription Use : No

Device Count : 1

E-LINK N400 Large Goniometer - 05060481690065 Catalog Number :

Device Description : Accurate measurements of upper and lower extremity ROM with precise electronic t Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting:Wrist, Forearm, Elbow, Shoulder, Hip, Knee, Ankle, Documentation of amputation, ankylosis, and arthrodesis for the above jointsThis product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

Device Class : 1

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : ISD, KQX

Prescription Use : No

Device Count : 1

E-LINK R500 ROM Kit (Range of Motion) - 05060481690072 Catalog Number :

Device Description : Accurate measurements of upper and lower extremity ROM with precise electronic t Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting.The Biometrics Range of Motion Kit (R500) provides precise electronic tools for:upper and lower extremity range of motion measurements

Device Class : 1

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : KQX, ISD

Prescription Use : No

Device Count : 1

Biometrics Ltd FP3 ForcePlate (0-100 Kg) - 05060481690089 Catalog Number :

Device Description : Each ForcePlate consists of a sandwich of 2 uniform precision metal plates, with Each ForcePlate consists of a sandwich of 2 uniform precision metal plates, with 4 load cells mounted between them. The vertical component of the total reaction force is measured independent of where it is applied over the surface of the plates.The relative light weight and small geometry of the plates aids in a wide range of upper and lower limb applications. The ForcePlates measure as little as the touch of a finger through to full standing weight bearing. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.

Device Class : 1

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : ION, ISD

Prescription Use : No

Device Count : 1

Biometrics Ltd M550 MyoMeter - 05060481690096 Catalog Number :

Device Description : The MyoMeter allows the user to quantify the force applied during Manual Muscle The MyoMeter allows the user to quantify the force applied during Manual Muscle Testing.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

Device Class : 2

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : IKK, ISD

Prescription Use : No

Device Count : 1

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