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510(k) K890143

ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON by Microcurrent Research, Inc. — Product Code NUW

K890143 is an FDA 510(k) premarket notification submitted by Microcurrent Research, Inc. for the device "ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON". The FDA issued a decision of Substantially Equivalent on May 1, 1989. The device falls under product code NUW (Stimulator, Muscle, Powered, Dental), a Class II device regulated under 21 CFR 890.5850. Microcurrent Research, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1989
Date Received
January 13, 1989
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 Microcurrent Research, Inc.

  • K981976 — ACUTRON MENTOR MODEL 961 (November 25, 1998)
  • K901902 — ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE (October 9, 1990)
  • K895977 — ACUSOURCE 600 (TENS) (January 9, 1990)

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)
  • K842224 — BNS 40 (November 19, 1984)
  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

FDA data resources