510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924315Substantially Equivalent

The Massager

Four Directions, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924315 is the FDA 510(k) clearance record for THE MASSAGER, a class I device, cleared for Four Directions on under FDA product code LYG (Massager, Therapeutic, Manual). FDA records list one 510(k) clearance for Four Directions. As of , FDA records show no recalls naming K924315.

Clearance record

Decision date
Received
(408 days to decision)
Product code
LYG Massager, Therapeutic, Manual
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Four Directions P.O. Box 55793, Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code LYG

Trailing 12 months

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

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