Device, Vibration Threshold Measurement
Device, Vibration Threshold Measurement is a neurological diagnostic device used to assess the sensory threshold for vibration perception, typically applied to the extremities to evaluate peripheral neuropathy, particularly in patients with diabetes mellitus, in which diminished vibration sense is an early sign of nerve damage. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is LLN, 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
- LLN
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K072882 | PAIN VISION, MODEL PS-2100 | Jan 08, 2009 | Substantially Equivalent | Osachi Co., Ltd. |
| K030829 | VPT METER | Dec 05, 2003 | Substantially Equivalent | Xilas Medical, Inc. |
| K010981 | GSA GENITO SENSORY ANALYZER | Sep 20, 2001 | Substantially Equivalent | Medoc Ltd. Advanced Medical Systems |
| K964622 | MEDI-DX 7000 | Dec 01, 1997 | Substantially Equivalent | Neuro-Diagnostic Assoc. |
| K964815 | AP-4000, AIR PULSE SENSORY STIMULATOR | Sep 04, 1997 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K970180 | VSA 3000 VIBRATORYN SENSORY ANALYZER | Apr 25, 1997 | Substantially Equivalent | Eare Consulting Service |
| K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | Aug 11, 1994 | Substantially Equivalent | Nk Biotechnical Engineering Co. |
| K921560 | VIBROTACTILE TESTER, MODEL NO. VTT-100 | Oct 30, 1992 | Substantially Equivalent | Topical Testing, Inc. |
| K910624 | CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 | Jan 17, 1992 | Substantially Equivalent | Wr Medical Electronics Co. |
| K872931 | TECA/MEDELEC TTT THERMAL THRESHOLD TESTER | Nov 16, 1987 | Substantially Equivalent | Teca, Inc. |
| K863607 | VIBRATRON II, VIBRATION SENSITIVITY TESTER | Dec 03, 1986 | Substantially Equivalent | Sensortek, Inc. |
| K853608 | NEUROMETER | Jun 12, 1986 | Substantially Equivalent | Neurotron, Inc. |
| K843486 | VIBRAMETER | Dec 24, 1984 | Substantially Equivalent | Somedic AB |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.