Cleared Traditional

K000736 - LA JOIE

K000736 is an FDA 510(k) clearance for LA JOIE, manufactured by Goomi Ehwa, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HED cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K000736 · Goomi Ehwa, Inc. · Obstetrics & Gynecology device
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Aug 2000
Decision
154d
Days
Class 1
Risk

K000736 is an FDA 510(k) clearance for the LA JOIE. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by Goomi Ehwa, Inc. (Cupertino, US). The FDA issued a Cleared decision on August 8, 2000 after a review of 154 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5900 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Goomi Ehwa, Inc. devices

FDA 510(k) Submission Details - K000736

510(k) Number K000736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2000
Decision Date August 08, 2000
Days to Decision 154 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 160d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

HED Device Classification - Class 1, General Controls

Product Code HED Douche Apparatus, Vaginal, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HED Douche Apparatus, Vaginal, Therapeutic

Devices cleared under the same product code (HED) and FDA review panel - the closest regulatory comparables to K000736.
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