510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901902Substantially Equivalent

Acusource 600 for Use with Tmj Electrode

Microcurrent Research, Inc., New Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901902 is the FDA 510(k) clearance record for ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE, a class II device, cleared for Microcurrent 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 4 510(k) clearances for Microcurrent Research, Inc., from to . As of , FDA records show no recalls naming K901902.

Clearance record

Decision date
Received
(165 days to decision)
Product code
NUW Stimulator, Muscle, Powered, Dental
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Microcurrent Research, Inc. 1440 Whalley Ave., New Haven CT
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