Duns Number:757139956
Device Description: Professional Suite is a wireless medical device that measures, records, and reports moveme Professional Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
Catalog Number
PS100
Brand Name
Professional Suite
Version/Model Number
0000PS100000000000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163150
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
9945b095-c96d-491e-8bbc-cf131780c6aa
Public Version Date
October 04, 2019
Public Version Number
1
DI Record Publish Date
September 26, 2019
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |