Duns Number:078582655
Device Description: Protekt Pilot Upright Walker Aluminum w/ Stand Assist Handles w/ 19" Seat w/ LED Light - B Protekt Pilot Upright Walker Aluminum w/ Stand Assist Handles w/ 19" Seat w/ LED Light - Blue
Catalog Number
UPWLKALDLX19BL
Brand Name
Protekt Pilot
Version/Model Number
UPWLKALDLX19BL
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
ITJ
Product Code Name
Walker, Mechanical
Public Device Record Key
d67e925d-b572-4c1e-9ac6-f09f8145d6bb
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
April 12, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |