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510(k) K040400

MYO-TRODE SG DISPOSABLE ELECTRODE by Myotronics-Noromed, Inc. — Product Code NUW

K040400 is an FDA 510(k) premarket notification submitted by Myotronics-Noromed, Inc. for the device "MYO-TRODE SG DISPOSABLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 20, 2004. The device falls under product code NUW (Stimulator, Muscle, Powered, Dental), a Class II device regulated under 21 CFR 890.5850. Myotronics-Noromed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2004
Date Received
February 17, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, Dental
Device Class
Class II
Regulation Number
890.5850
Review Panel
DE
Submission Type

Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.

Other clearances by Myotronics-Noromed, Inc.

  • K111687 — EMG SYSTEM (September 29, 2011)
  • K031998 — MODEL J-5 MVO-MONITOR (July 24, 2003)
  • K013399 — MODEL MES-9000/EMG SYSTEM (November 13, 2001)
  • K003287 — MODEL K7 EVALUATION DEVICE (November 6, 2000)
  • K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (September 10, 1999)
  • K992439 — NORODYN 8000 SEMG SYSTEM, ND-8000 (August 13, 1999)

Other clearances for product code NUW

  • K243290 — BTL-785MJ (May 9, 2025)
  • K203525 — D function (May 5, 2021)
  • K031998 — MODEL J-5 MVO-MONITOR (July 24, 2003)
  • K901902 — ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE (October 9, 1990)
  • K890143 — ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON (May 1, 1989)
  • K842224 — BNS 40 (November 19, 1984)
  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

FDA data resources