Duns Number:041477449
Device Description: A device consisting of a lever(s), spring(s), tyre contact pads, or other mechanism used t A device consisting of a lever(s), spring(s), tyre contact pads, or other mechanism used to slow down, stop, and/or hold a wheelchair in a stationary position. This also includes the necessary installation package.
Catalog Number
N/A
Brand Name
WHEELCHAIR BRAKES
Version/Model Number
WHEELCHAIR BRAKES
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMW
Product Code Name
Brake, Extension, Wheelchair
Public Device Record Key
d64fb02b-662c-4a10-9ab0-d1c0d9fa70ae
Public Version Date
September 03, 2019
Public Version Number
1
DI Record Publish Date
August 26, 2019
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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 296 |