Duns Number:037304144
Device Description: MOBILECARE STRETCHER WITH KNEE GATCH. PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJUST RANGE O MOBILECARE STRETCHER WITH KNEE GATCH. PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJUST RANGE OF 23" TO 36". PEDALS LOCATED ON EITHER SIDE. +/- 18 DEGREE TRENDELENBURG AND REVERSE TRENDELEBURG, ADJUSTMENT PEDALS ON EITHER SIDE. FOLD FORWARD SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDALS LOCATED ON ALL 4 CORNERS. REMOVABLE 2 HOOK I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB.
Catalog Number
FHC7100-KNEE
Brand Name
PERSONAL TRANSPORT STRETCHER
Version/Model Number
FHC7100-KNEE
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
5f364c0a-3d29-4937-b573-cc201c56eed8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 10, 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 | 287 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |