LEGSys

Basic Information

• Brand Name: LEGSys
• Primary DI: B654LS0
• Version / Model: LEGSys
• Company Name: BIOSENSICS LLC
• Labeler DUNS: 802270988
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-12
• Public Version: 2
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 845b834a-4735-49f4-9d5c-b7ce33a9e80b

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12391	Wearable multiple physiological parameter recorder, reusable	An 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, electrocardiogram (ECG), 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 smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B654LS0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]