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510(k) K070109

NEUROMETRIX ADVANCE by Neurometrix, Inc. — Product Code JXE

K070109 is an FDA 510(k) premarket notification submitted by Neurometrix, Inc. for the device "NEUROMETRIX ADVANCE". The FDA issued a decision of Substantially Equivalent on April 25, 2008. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550. Neurometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2008
Date Received
January 11, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Nerve Conduction Velocity Measurement
Device Class
Class II
Regulation Number
882.1550
Review Panel
NE
Submission Type

Other clearances by Neurometrix, Inc.

  • DEN210046 — Quell-FM (May 18, 2022)
  • K152954 — Quell (January 5, 2016)
  • K140586 — ASCEND ELECTRODE (November 17, 2014)
  • K140333 — ASCEND (July 3, 2014)
  • K130919 — SENSUS (July 2, 2013)
  • K121816 — SENSUS ELECTRODE (November 26, 2012)
  • K121184 — SENSUS (August 2, 2012)
  • K091155 — ASCEND (September 3, 2009)
  • K083322 — NEUROMETRIX BIOAMPLIFIER (May 27, 2009)
  • K083818 — UNIVERSAL ELECTRODES (January 21, 2009)

Other clearances for product code JXE

  • K240189 — NM-01/CPT neurometer (NM-01/CPT) (March 26, 2025)
  • K190536 — Mediracer NCS (September 25, 2019)
  • K060584 — NC-STAT (July 31, 2006)
  • K053058 — XLTEK NEUROPATH, MODEL PK1070 (February 7, 2006)
  • K052904 — VIRTUAL MEDICAL SYSTEMS MODEL VT3000 (October 27, 2005)
  • K041320 — MODIFICATION TO NC-STAT (August 12, 2004)
  • K013459 — MODIFICATION OF NC-STAT (January 17, 2002)
  • K012069 — MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT (August 1, 2001)
  • K003508 — NC-STAT (January 17, 2001)
  • K001692 — NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (November 24, 2000)

FDA data resources