Duns Number:051957769
Device Description: It is a motor driven, indoor and outdoor transportation vehicle with the intended use to p It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. Device Description: Front and rear 8-inch solid wheels, acid batteries,black and red color of the scooter shell,with headlight.
Catalog Number
-
Brand Name
Equate
Version/Model Number
W3431D
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"
Yes
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
INI
Product Code Name
Vehicle, Motorized 3-Wheeled
Public Device Record Key
f652b8e4-3417-42cc-b800-60919ffd14c8
Public Version Date
June 27, 2022
Public Version Number
1
DI Record Publish Date
June 18, 2022
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |