Identity
- Trade Name
- Noromed NT-360 Inclinometer FDA UDI
- Generic Name
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- NT360 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D792N36010 FDA UDI
- FDA Product Code
- KQX FDA UDIHCC FDA UDI
- GMDN Term
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1500 FDA UDI882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Virtual-display rehabilitation system, non-supportive, clinical
Noromed NT-360 Inclinometer by Myotronics-Noromed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Myotronics-Noromed, Inc.
Sources (1)
- FDA UDI b4f879b3-29ab-43a2-b829-94498f22f9ff 33 fields · synced May 31, 2026