510(k) K183585
K183585 is an FDA 510(k) premarket notification submitted by Elidah, Inc. for the device "Elitone Device". The FDA issued a decision of Substantially Equivalent on Feb 11, 2019. The device falls under product code QAJ (Cutaneous Electrode Stimulator For Urinary Incontinence), a Class II device regulated under 21 CFR 876.5330. Elidah, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 2019
- Date Received
- Dec 21, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cutaneous Electrode Stimulator For Urinary Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5330
- Review Panel
- GU
- Submission Type
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.