Noromed NT-360 Inclinometer

GUDID D792N9360A0

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.

MYOTRONICS NOROMED, INC

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• Primary Device ID: D792N9360A0
• NIH Device Record Key: b4f879b3-29ab-43a2-b829-94498f22f9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noromed NT-360 Inclinometer
• Version Model Number: NT360
• Company DUNS: 053824652
• Company Name: MYOTRONICS NOROMED, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D792N36010 [Primary]
HIBCC	D792N9360A0 [Package]; Contains: D792N36010; Package: [2 Units]

FDA Product Code

• KQX: Goniometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-11

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