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510(k) K243290

BTL-785MJ by BTL Industries, Inc. — Product Code NUW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2025
Date Received
October 18, 2024
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 BTL Industries, Inc.

  • K252561 — BTL-754FF (February 18, 2026)
  • K250309 — BTL-199 (August 7, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241270 — BTL-754 (January 30, 2025)
  • K242532 — BTL-785BNF-E (December 13, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233849 — BTL-499 (April 23, 2024)
  • K233604 — BTL-785S (March 28, 2024)
  • K230657 — BTL-99-OC (February 1, 2024)
  • K232937 — BTL-899M (December 26, 2023)

Other clearances for product code NUW

  • 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)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)