Duns Number:605813559
Device Description: Zephyr IR-S Hoverboard with mounts for Skull Clamp for Philips MR. Includes the Zephyr IR Zephyr IR-S Hoverboard with mounts for Skull Clamp for Philips MR. Includes the Zephyr IR-S Hoverboard, Patient Pad with integrated Transfer Handles, Integrated IV Pole, Hoverboard Security Straps, and Patient Security Straps
Catalog Number
-
Brand Name
Zephyr Patient Positioning and Transfer System
Version/Model Number
ZXL-IRS-20
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121929
Product Code
FRZ
Product Code Name
Device, Patient Transfer, Powered
Public Device Record Key
5b5a7f0e-b26a-4c85-9316-69f51887487a
Public Version Date
December 29, 2021
Public Version Number
1
DI Record Publish Date
December 21, 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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 107 |