510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904025Substantially Equivalent

Myotrack, Model Hh 515

Myotrack Co., Van Nuys CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904025 is the FDA 510(k) clearance record for MYOTRACK, MODEL HH 515, a class II device, cleared for Myotrack Co. on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list one 510(k) clearance for Myotrack Co. As of , FDA records show no recalls naming K904025.

Clearance record

Decision date
Received
(183 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Myotrack Co. P.O. Box 56025, Van Nuys CA
Third party review
No

Clearances, product code BXN

Trailing 12 months

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

FDA records show no clearances under product code BXN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXN, 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