Elitone Device

Cutaneous Electrode Stimulator For Urinary Incontinence

Elidah, Inc.

The following data is part of a premarket notification filed by Elidah, Inc. with the FDA for Elitone Device.

Pre-market Notification Details

Device IDK183585
510k NumberK183585
Device Name:Elitone Device
ClassificationCutaneous Electrode Stimulator For Urinary Incontinence
Applicant Elidah, Inc. 810 Main St., Ste C Monroe,  CT  06468
ContactGloria Kolb
CorrespondentGloria Kolb
Elidah, Inc. 810 Main St., Ste C Monroe,  CT  06468
Product CodeQAJ  
CFR Regulation Number876.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-21
Decision Date2019-02-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851096008018 K183585 000
00851096008001 K183585 000
00851096008025 K183585 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.