LQW · Test, Temperature Discrimination
Neurology · 21 CFR 882.1200 · Class 1
Overview
| Product Code | LQW |
|---|---|
| Device Name | Test, Temperature Discrimination |
| Regulation | 21 CFR 882.1200 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A two-point discriminator is a device with points used for testing a patient's touch discrimination.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141208 | DYNAMIC NEUROSCREENING DEVICE | Prosenex | Jul 23, 2014 | SESE |
| K922052 | TSA 2001 THERMAL SENSORY ANALYZER | Medoc Corp. | Oct 21, 1993 | SESE |
| K864345 | NTE-2 THERMAL SENSITIVITY TESTER | Sensortek, Inc. | Jan 29, 1987 | SESE |
Top Applicants
- Medoc Corp. — 1 clearance
- Prosenex — 1 clearance
- Sensortek, Inc. — 1 clearance
