510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000736Substantially Equivalent

La Joie

Goomi Ehwa, Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000736 is the FDA 510(k) clearance record for LA JOIE, a class I device, cleared for Goomi Ehwa, Inc. on under FDA product code HED (Douche Apparatus, Vaginal, Therapeutic). FDA records list one 510(k) clearance for Goomi Ehwa, Inc. As of , FDA records show no recalls naming K000736.

Clearance record

Decision date
Received
(154 days to decision)
Product code
HED Douche Apparatus, Vaginal, Therapeutic
Regulation
21 CFR 884.5900
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Goomi Ehwa, Inc. P.O. Box 2123, Cupertino CA
510(k) summary
Statement
Third party review
No

Clearances, product code HED

Trailing 12 months

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

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