Duns Number:080949236
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 position to a passive standing position and have mobility.
Catalog Number
TEKRMD05
Brand Name
Tek RMD
Version/Model Number
05
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
K191334
Product Code
IPL
Product Code Name
Wheelchair, Standup
Public Device Record Key
882cc701-b52d-4869-b893-b4c75361a80c
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 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. | 8 |