Duns Number:502675133
Device Description: The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander. It bring The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander. It brings person from seated positionto a passive standing position and have mobility.
Catalog Number
TEKRMD01
Brand Name
TEK Robotic Mobilization Device
Version/Model Number
01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IPL
Product Code Name
Wheelchair, Standup
Public Device Record Key
b4c41715-b47c-4fe7-93c3-ab105e3baf54
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2016
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 |