Duns Number:656139839
Device Description: Compact Mid-Wheel Drive Power Chair
Catalog Number
-
Brand Name
CTM
Version/Model Number
HS-2850
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
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
278abfab-b406-4d9c-a568-7ebd8e9709bc
Public Version Date
December 25, 2020
Public Version Number
1
DI Record Publish Date
December 17, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |