510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243290Substantially Equivalent

Btl-785Mj

BTL Industries, Inc, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243290 is the FDA 510(k) clearance record for BTL-785MJ, a class II device, cleared for BTL Industries, Inc. on under FDA product code NUW (Stimulator, Muscle, Powered, Dental). FDA's definition for product code NUW reads: "Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow". FDA records list 45 510(k) clearances for BTL Industries, Inc., from to . As of , FDA records show no recalls naming K243290.

Clearance record

Decision date
Received
(203 days to decision)
Product code
NUW Stimulator, Muscle, Powered, Dental
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
BTL Industries, Inc. 362 Elm St., Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUW

Trailing 12 months

FDA records hold no clearances under product code NUW in the trailing twelve months.

FDA records show no clearances under product code NUW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NUW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260