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510(k) K935017

TD50 ELECTROMYOGRAPH by Medelec Intl. Corp. — Product Code JXE

K935017 is an FDA 510(k) premarket notification submitted by Medelec Intl. Corp. for the device "TD50 ELECTROMYOGRAPH". The FDA issued a decision of Substantially Equivalent on July 28, 1994. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550. Medelec Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1994
Date Received
October 19, 1993
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 Medelec Intl. Corp.

  • K961013 — DISPOSABLE NEEDLE ELECTRODE (December 20, 1996)
  • K922548 — MEDELEC 2110 AND 2114 EEG (November 3, 1992)
  • K920127 — ELECTROENCEPHALOGRAPH RECORDING SYSTEM (June 10, 1992)
  • K912775 — SAPPHIRE 4ME EMG/EP SYSTEM (November 8, 1991)
  • K865106 — PROPHYLACTIC (CONDOM) MR. JOHNNY (May 20, 1987)
  • K863491 — BLOOD SPECIMEN COLLECTION DEVICES (October 24, 1986)
  • K854622 — PROPHYLACTIC (CONDOM) (April 11, 1986)
  • K854562 — CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I (January 9, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K854860 — BLADES, SCALPEL CARBON STEET (December 24, 1985)

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