LLN — Device, Vibration Threshold Measurement Class I
FDA product code LLN covers "Device, Vibration Threshold Measurement", a Class I medical device regulated under 21 CFR 882.1200. Submissions are reviewed by the Neurology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LLN
- Device Class
- Class I
- Regulation Number
- 882.1200
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K072882 | osachi co | PAIN VISION, MODEL PS-2100 | January 8, 2009 |
| K030829 | xilas medical | VPT METER | December 5, 2003 |
| K010981 | medoc ltd. advanced medical systems | GSA GENITO SENSORY ANALYZER | September 20, 2001 |
| K964622 | neuro-diagnostic assoc | MEDI-DX 7000 | December 1, 1997 |
| K964815 | pentax precision instrument | AP-4000, AIR PULSE SENSORY STIMULATOR | September 4, 1997 |
| K970180 | eare consulting service | VSA 3000 VIBRATORYN SENSORY ANALYZER | April 25, 1997 |
| K934368 | nk biotechnical engineering | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | August 11, 1994 |
| K921560 | topical testing | VIBROTACTILE TESTER, MODEL NO. VTT-100 | October 30, 1992 |
| K910624 | wr medical electronics | CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 | January 17, 1992 |
| K872931 | teca | TECA/MEDELEC TTT THERMAL THRESHOLD TESTER | November 16, 1987 |
| K863607 | sensortek | VIBRATRON II, VIBRATION SENSITIVITY TESTER | December 3, 1986 |
| K853608 | neurotron | NEUROMETER | June 12, 1986 |
| K843486 | somedic | VIBRAMETER | December 24, 1984 |