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

Device, Biofeedback (HCC) (2) Exerciser, Measuring (ISD) (2) Exerciser, Non-Measuring (ION) (1) Exerciser, Powered (BXB) (1)

Premarket Exempt

Yes

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E-LINK Myo-EX GX2 EMG Sensor - 05060481692458 Catalog Number :

Device Description : Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginnin 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.GX2 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..This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13

Device Class : 2

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : HCC, ISD

Prescription Use : No

Device Count : 1

E-LINK EX2 Interface Unit for M400 - 05060481692465 Catalog Number :

Device Description : The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX (NC1, NC2) sensors to E3000 Serial Interface Upper Limb Exerciser.This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13

Device Class : 1

Duns Number: 519969810

Premarket Exempt : Yes

Product Code : HCC, ISD, BXB, ION

Prescription Use : No

Device Count : 1

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