Duns Number:802270988
Device Description: LEGSys™ is a wireless wearable system based on 9 degree-of-freedom inertial measurement se 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.
Catalog Number
-
Brand Name
LEGSys
Version/Model Number
LEGSys
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
ISD
Product Code Name
Exerciser, Measuring
Public Device Record Key
845b834a-4735-49f4-9d5c-b7ce33a9e80b
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
March 12, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |