Duns Number:011245388
Device Description: Flyer models are manual wheelchairs intended to provide mobility to a person with disabili Flyer models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
Catalog Number
905088
Brand Name
Flyer
Version/Model Number
FL12
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171017
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
3a4c4604-364f-4e08-8a39-3814e6fb9585
Public Version Date
May 02, 2022
Public Version Number
2
DI Record Publish Date
September 24, 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 | 5 |