LLN · Device, Vibration Threshold Measurement
Neurology · 21 CFR 882.1200 · Class 1
Overview
| Product Code | LLN |
|---|---|
| Device Name | Device, Vibration Threshold Measurement |
| 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072882 | PAIN VISION, MODEL PS-2100 | Osachi Co., Ltd. | Jan 8, 2009 | SESE |
| K030829 | VPT METER | Xilas Medical, Inc. | Dec 5, 2003 | SESE |
| K010981 | GSA GENITO SENSORY ANALYZER | Medoc Ltd. Advanced Medical Systems | Sep 20, 2001 | SESE |
| K964622 | MEDI-DX 7000 | Neuro-Diagnostic Assoc. | Dec 1, 1997 | SESE |
| K964815 | AP-4000, AIR PULSE SENSORY STIMULATOR | Pentax Precision Instrument Corp. | Sep 4, 1997 | SESE |
| K970180 | VSA 3000 VIBRATORYN SENSORY ANALYZER | Eare Consulting Service | Apr 25, 1997 | SESE |
| K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | Nk Biotechnical Engineering Co. | Aug 11, 1994 | SESE |
| K921560 | VIBROTACTILE TESTER, MODEL NO. VTT-100 | Topical Testing, Inc. | Oct 30, 1992 | SESE |
| K910624 | CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 | Wr Medical Electronics Co. | Jan 17, 1992 | SESE |
| K872931 | TECA/MEDELEC TTT THERMAL THRESHOLD TESTER | Teca, Inc. | Nov 16, 1987 | SESE |
| K863607 | VIBRATRON II, VIBRATION SENSITIVITY TESTER | Sensortek, Inc. | Dec 3, 1986 | SESE |
| K853608 | NEUROMETER | Neurotron, Inc. | Jun 12, 1986 | SESE |
| K843486 | VIBRAMETER | Somedic AB | Dec 24, 1984 | SESE |
Top Applicants
- Eare Consulting Service — 1 clearance
- Medoc Ltd. Advanced Medical Systems — 1 clearance
- Neuro-Diagnostic Assoc. — 1 clearance
- Neurotron, Inc. — 1 clearance
- Nk Biotechnical Engineering Co. — 1 clearance
