BIOSENSICS LLC

Address:57 Chapel Street, Suite 200,Newton,MA,02458,US

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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) (1)

Premarket Exempt

Yes

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LEGSys - B654LS0 Catalog Number :

Device Description : LEGSys™ is a wireless wearable system based on 9 degree-of-freedom inertial meas LEGSys™ is a wireless wearable system based on 9 degree-of-freedom inertial measurement sensors. LEGSys™ is intended for measuring spatiotemporal parameters of gait based on the joint angles of the lower limbs during human walking over ground or on a treadmill. Additionally for patients aged 70 and up, LEGSys™ is intended to assess a patient’s risk of falling based on measured spatiotemporal parameters of gait and published, publicly available, scientific data regarding fall risk.

Device Class : 2

Duns Number: 802270988

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : No

Device Count : 1

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