Device, Vibration Threshold Measurement
FDA product code LLN · Class I (low risk) · 21 CFR 882.1200 · Neurology
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Somedic AB 1
- Neurotron, Inc. 1
- Sensortek, Inc. 1
- Teca, Inc. 1
- Wr Medical Electronics Co. 1
- Topical Testing, Inc. 1
- Nk Biotechnical Engineering Co. 1
- Eare Consulting Service 1
- Pentax Precision Instrument Corp. 1
- Neuro-Diagnostic Assoc. 1
- Medoc Ltd. Advanced Medical Systems 1
- Xilas Medical, Inc. 1
- Osachi Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072882 | Pain Vision, Model PS-2100LLN · Traditional | Osachi Co., Ltd. | 01/08/2009SE |
| K030829 | VPT MeterLLN · Traditional | Xilas Medical, Inc. | 12/05/2003SE |
| K010981 | Gsa Genito Sensory AnalyzerLLN · Traditional | Medoc Ltd. Advanced Medical Systems | 09/20/2001SE |
| K964622 | Medi-Dx 7000LLN · Traditional | Neuro-Diagnostic Assoc. | 12/01/1997SE |
| K964815 | AP-4000, Air Pulse Sensory StimulatorLLN · Traditional | Pentax Precision Instrument Corp. | 09/04/1997SE |
| K970180 | Vsa 3000 Vibratoryn Sensory AnalyzerLLN · Traditional | Eare Consulting Service | 04/25/1997SE |
| K934368 | NK Pressure-Specified Sensory Device, Model PSSD-001LLN · Traditional | Nk Biotechnical Engineering Co. | 08/11/1994SE |
| K921560 | Vibrotactile Tester, Model No. VTT-100LLN · Traditional | Topical Testing, Inc. | 10/30/1992SE |
| K910624 | Case IV Computer Aided Sensory Evaluator Version 4LLN · Traditional | Wr Medical Electronics Co. | 01/17/1992SE |
| K872931 | Teca/Medelec TTT Thermal Threshold TesterLLN · Traditional | Teca, Inc. | 11/16/1987SE |
| K863607 | Vibratron II, Vibration Sensitivity TesterLLN · Traditional | Sensortek, Inc. | 12/03/1986SE |
| K853608 | NeurometerLLN · Traditional | Neurotron, Inc. | 06/12/1986SE |
| K843486 | VibrameterLLN · Traditional | Somedic AB | 12/24/1984SE |