LEGSys

GUDID B654LS0

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.

BIOSENSICS LLC

Wearable multiple physiological parameter recorder

• Primary Device ID: B654LS0
• NIH Device Record Key: 845b834a-4735-49f4-9d5c-b7ce33a9e80b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEGSys
• Version Model Number: LEGSys
• Company DUNS: 802270988
• Company Name: BIOSENSICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com
• Phone: 8885896213
• Email: support@biosensics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B654LS0 [Primary]

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12