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510(k) K842223

J4 MYO-MONITOR by Myo-Tronics Research, Inc. — Product Code NUW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1984
Date Received
June 5, 1984
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 Myo-Tronics Research, Inc.

  • K842224 — BNS 40 (November 19, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K831364 — TESTCORP RA (May 27, 1983)
  • K830034 — MODEL EM-2 BIOELECTRIC PROCESSOR (February 9, 1983)
  • K813533 — ELECTRIC MUSCLE STIMULATOR (March 5, 1982)
  • K810528 — MODEL EM-IR (March 31, 1981)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

Other clearances for product code NUW

  • K243290 — BTL-785MJ (May 9, 2025)
  • K203525 — D function (May 5, 2021)
  • K040400 — MYO-TRODE SG DISPOSABLE ELECTRODE (July 20, 2004)
  • 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)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)