Duns Number:548310008
Device Description: Weight: 26.6kg, L1005mm*615mm*1270mmHY108 are versatile mobile lifts intended mainly f Weight: 26.6kg, L1005mm*615mm*1270mmHY108 are versatile mobile lifts intended mainly for use in health care, intensive care and rehabilitation.HY108 is excellent aids for daily transfers of adults, bariatrics and children, for instance, lifting to and from wheel chair, bed ,toilet and floor .A Viking equipped with armrests can be used for gait training by patients. Horizontal lifting is also possible with any of the HF stretchers.
Catalog Number
-
Brand Name
Hi-Fortune
Version/Model Number
HY108
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
-
Product Code
FNG
Product Code Name
Lift, Patient, Ac-Powered
Public Device Record Key
8cdf25cd-a6d7-48c5-adcc-6b13776bfefa
Public Version Date
March 31, 2022
Public Version Number
1
DI Record Publish Date
March 23, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |