LEGSys

Primary DI
B654LS0
Brand
LEGSys
Company
BIOSENSICS LLC
Model
LEGSys
Device description
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.
Published
2021-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B654LS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorderAn electrically-powered, wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiograph, haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a local application (e.g., smartphone) or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8885896213support@biosensics.com

Regulatory Flags#

DUNS number
802270988
Device count
1
Premarket exempt
true

Other Devices Sharing Product Codes#

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00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
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