Duns Number:015704559
Device Description: The ActiveStep is an instrumented treadmill for pre-emptive rehabilitation, gait analysis The ActiveStep is an instrumented treadmill for pre-emptive rehabilitation, gait analysis and research. The ActiveStep system consists of a powered treadmill; harness and support structure; Intertial Measurement Unit (IMU) and computer for control and data acquisition.
Catalog Number
-
Brand Name
ActiveStep
Version/Model Number
008-C ActiveStep eTrip Edition
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IOL
Product Code Name
Treadmill, Powered
Public Device Record Key
72cec855-37b6-411f-8df8-630e2746b230
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |