Test, Temperature Discrimination
The Temperature Discrimination Test is a device used to evaluate a patient's ability to distinguish between different temperatures applied to the skin, serving as a neurological assessment tool for sensory function and detecting peripheral neuropathy or other somatosensory deficits. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LQW, regulated under 21 CFR 882.1200, within the Neurology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LQW
- Device Class
- FDA class 1
- Regulation Number
- 882.1200
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K141208 | DYNAMIC NEUROSCREENING DEVICE | Jul 23, 2014 | Substantially Equivalent | Prosenex |
| K922052 | TSA 2001 THERMAL SENSORY ANALYZER | Oct 21, 1993 | Substantially Equivalent | Medoc Corp. |
| K864345 | NTE-2 THERMAL SENSITIVITY TESTER | Jan 29, 1987 | Substantially Equivalent | Sensortek, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.