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510(k) K203525

D function by Ito Co., Ltd. — Product Code NUW

K203525 is an FDA 510(k) premarket notification submitted by Ito Co., Ltd. for the device "D function". The FDA issued a decision of Substantially Equivalent on May 5, 2021. The device falls under product code NUW (Stimulator, Muscle, Powered, Dental), a Class II device regulated under 21 CFR 890.5850. Ito Co., Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2021
Date Received
December 1, 2020
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 Ito Co., Ltd.

  • K112520 — US-101L, US-103S (October 26, 2011)
  • K081943 — MODEL ES-130 (November 24, 2008)
  • K081247 — TM-400 (August 25, 2008)
  • K032793 — US-100 PORTABLE ULTRASOUND THERAPY UNIT (October 9, 2003)
  • K022846 — SW-180 SHORTWAVE THERAPY UNIT (January 28, 2003)
  • K990787 — TRIO 300 (October 20, 1999)
  • K992545 — TM-300 TRACTION SYSTEM (September 1, 1999)

Other clearances for product code NUW

  • K243290 — BTL-785MJ (May 9, 2025)
  • 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)
  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

FDA data resources