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510(k) K921504

REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS by Chalgren Enterprises, Inc. — Product Code JXE

K921504 is an FDA 510(k) premarket notification submitted by Chalgren Enterprises, Inc. for the device "REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550. Chalgren Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
March 31, 1992
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 Chalgren Enterprises, Inc.

  • K982950 — FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-55 (June 22, 1999)
  • K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-X (June 13, 1996)
  • K955335 — DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE (January 29, 1996)
  • K953361 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953356 — EMG RECORDING RING ELECTRODE (January 22, 1996)
  • K953354 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K952908 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K952690 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K953886 — RE-USABLE MONOPOLAR NEEDLE (October 31, 1995)
  • K953887 — RE-USABLE CONCENTRIC NEEDLE (October 31, 1995)

Other clearances for product code JXE

  • K240189 — NM-01/CPT neurometer (NM-01/CPT) (March 26, 2025)
  • K190536 — Mediracer NCS (September 25, 2019)
  • K070109 — NEUROMETRIX ADVANCE (April 25, 2008)
  • 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)

FDA data resources