Duns Number:117410715
Device Description: Battery powered device intended to evaluate joint function by measuring and recording rang Battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint
Catalog Number
28000
Brand Name
AccuAngle
Version/Model Number
28000
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
Yes
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
-
Product Code
KQX
Product Code Name
Goniometer, Ac-Powered
Public Device Record Key
774ecd71-68d3-42a2-aa27-68daee674f31
Public Version Date
October 12, 2020
Public Version Number
1
DI Record Publish Date
October 02, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |