Duns Number:428484518
Device Description: SMART is a System for motion analysis, intended for the recording and analysis of human mo SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of rehabilitation, sports medicine,ergonomics, clinical research.
Catalog Number
BTSSDX
Brand Name
SMART
Version/Model Number
DX
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131660
Product Code
LXJ
Product Code Name
System, Optical Position/Movement Recording
Public Device Record Key
374b11e7-c7ef-4099-9dda-0a42be68c49b
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
February 12, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |