Home / 510(k) Clearances / K770252

510(k) K770252

MONITOR, MYO, MODEL J3 by Myo-Tronics Research, Inc. — Product Code NUW

K770252 is an FDA 510(k) premarket notification submitted by Myo-Tronics Research, Inc. for the device "MONITOR, MYO, MODEL J3". The FDA issued a decision of Substantially Equivalent on February 18, 1977. The device falls under product code NUW (Stimulator, Muscle, Powered, Dental), a Class II device regulated under 21 CFR 890.5850. Myo-Tronics Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1977
Date Received
February 9, 1977
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)
  • K842223 — J4 MYO-MONITOR (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)

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)
  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K842224 — BNS 40 (November 19, 1984)

FDA data resources