Home / 510(k) Clearances / K243290

510(k) K243290

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

K243290 is an FDA 510(k) premarket notification submitted by BTL Industries, Inc. for the device "BTL-785MJ". The FDA issued a decision of Substantially Equivalent on May 9, 2025. The device falls under product code NUW (Stimulator, Muscle, Powered, Dental), a Class II device regulated under 21 CFR 890.5850. BTL Industries, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K252963 — BTL-899TT (June 12, 2026)
  • K253750 — BTL-785NEH (March 17, 2026)
  • 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)

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

FDA data resources