Home / 510(k) Clearances / K072882

510(k) K072882

PAIN VISION, MODEL PS-2100 by Osachi Co., Ltd. — Product Code LLN

K072882 is an FDA 510(k) premarket notification submitted by Osachi Co., Ltd. for the device "PAIN VISION, MODEL PS-2100". The FDA issued a decision of Substantially Equivalent on January 8, 2009. The device falls under product code LLN (Device, Vibration Threshold Measurement), a Class I device regulated under 21 CFR 882.1200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2009
Date Received
October 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vibration Threshold Measurement
Device Class
Class I
Regulation Number
882.1200
Review Panel
NE
Submission Type

Other clearances for product code LLN

  • K030829 — VPT METER (December 5, 2003)
  • K010981 — GSA GENITO SENSORY ANALYZER (September 20, 2001)
  • K964622 — MEDI-DX 7000 (December 1, 1997)
  • K964815 — AP-4000, AIR PULSE SENSORY STIMULATOR (September 4, 1997)
  • K970180 — VSA 3000 VIBRATORYN SENSORY ANALYZER (April 25, 1997)
  • K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (August 11, 1994)
  • K921560 — VIBROTACTILE TESTER, MODEL NO. VTT-100 (October 30, 1992)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)
  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)

FDA data resources