Duns Number:625089131
Device Description: A device to assist the clinician with establishing an objective assessment of a person’s r A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
Catalog Number
-
Brand Name
Northstar Echo Secondary Inclinometer
Version/Model Number
9RF404
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
KQX
Product Code Name
Goniometer, Ac-Powered
Public Device Record Key
f1bc5737-eb41-4c27-b0eb-8303834b0742
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 14, 2021
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 | 19 |
| U | Unclassified | 3 |