Duns Number:519969810
Device Description: Mains powered battery charging unit for up to 8 wireless DataLITE sensors (LE230, W series Mains powered battery charging unit for up to 8 wireless DataLITE sensors (LE230, W series Goniometers, Z series Torsiometers, AD2, ACL500).Includes Medical Grade Power Supply and country specific mains power cord..This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
Catalog Number
-
Brand Name
DataLITE CA2 Battery Charger
Version/Model Number
CA2
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"
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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
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
88746fed-3663-47be-95aa-5664d6c8c412
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
August 09, 2018
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |