Duns Number:053824652
Device Description: By using sophisticated sensors within the inclinometers, the Dynamic ROM system records th By using sophisticated sensors within the inclinometers, the Dynamic ROM system records the patient's entire ROM through the plane of movement and displays it in a graphical representation on the computer screen. Unlike other systems which simply give you a static endpoint measurement of ROM, Dynamic ROM captures the entire movement. The figure to your left shows a typical Dynamic ROM recording of the dynamic motion of the spine during three repetitions of lumbar flexion and extension. The numbers correspond with the figure to the left showing the patient's motions.The inclinometers are attached to straps placed over T12 and S1. The recording of the sensor at S1 is subtracted from the recording at T12 to produce the DIFFerential recording graph which represents the true motion of the patient's lumbar during lumbar flexion and extension motion. The flattened DIFF tracing line on each repetition during end-point indicates that both sensors are moving at the same rate of speed, and that the lumbar lordosis stopped unfolding before the end-point of trunk flexion had been reached. With this information the clinician can observe and assess the quality and the pattern of the patient's motion as well as the quantity of the ROM. Dynamic Range of Motion from Noromed elevates range of motion testing from a simple measurement tool to a true diagnostic tool.
Catalog Number
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Brand Name
Noromed NT-360 Inclinometer
Version/Model Number
NT360
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
b4f879b3-29ab-43a2-b829-94498f22f9ff
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
February 11, 2017
Package DI Number
D792N9360A0
Quantity per Package
2
Contains DI Package
D792N36010
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |