510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842223Substantially Equivalent

J4 Myo-Monitor

Myo-Tronics Research, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842223 is the FDA 510(k) clearance record for J4 MYO-MONITOR, a class II device, cleared for Myo-Tronics Research, 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 8 510(k) clearances for Myo-Tronics Research, Inc., from to . As of , FDA records show no recalls naming K842223.

Clearance record

Decision date
Received
(167 days to decision)
Product code
NUW Stimulator, Muscle, Powered, Dental
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Myo-Tronics Research, Inc. 803 N. Front St. Suite 3, Mchenry IL
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