Product Code: LQW FDA class 1 21 CFR 882.1200

Test, Temperature Discrimination

Neurology

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.

510(k)s
3
FEI Numbers
4
Registration Numbers
4
Unique Applicants
3
Years Active
27

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 3 510(k) clearances via K numbers.

K Number Device Name
K141208 DYNAMIC NEUROSCREENING DEVICE
K922052 TSA 2001 THERMAL SENSORY ANALYZER
K864345 NTE-2 THERMAL SENSITIVITY TESTER

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.