Duns Number:188660844
Device Description: EYE MOBILE-CARE STRETCHER WITH CLEARLY MARKED HEIGHT ADJUSTMENT PEDALS ON BOTH SIDES FROM EYE MOBILE-CARE STRETCHER WITH CLEARLY MARKED HEIGHT ADJUSTMENT PEDALS ON BOTH SIDES FROM 23"TO 36" HIGH. TRENDELEBURG AND REVERSE TRENDELENBURG ADJUSTMENT PEDALS ON BOTH SIDES. CRANK BACKREST AND KNEE GATCH. DUAL ARTICULATION TAPERED HEADPIECE. FOLD DOWN SIDE RAILS. BUILT IN OXGEN CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDAL AT EACH CORNER. I.V. POLE AND 4" MATTRESS INCLUDED. PATIENT SURFACE 88" X 26" WITH 550 LB CAPACITY.
Catalog Number
FHC7100-EYE1
Brand Name
PERSONAL TRANSPORT STRETCHER W ITH HEAD REST
Version/Model Number
FHC7100-EYE1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
FPO
Product Code Name
Stretcher, Wheeled
Public Device Record Key
70bd0a0c-2d26-45f4-8dfc-5cdca212ab71
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 26, 2016
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 | 456 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |